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1. to national 3 For assistance questions or assistance in notifying your accounts about this correction please contact Zimmer This voluntary action will be reported to the U S Food and Drug Administration amp International Competent Authorities The FDA amp Competent Authorities will also receive from Zimmer progress reports on the implementation of this recall Your urgent cooperation is requested Vigilance Reporting Any adverse reactions experienced with the use of these products and or quality problems may also be reported according to MEDDEV 2 12 1 Rev 6 to the local health authority in your country Zimmer Product Scope Table 1 Part Number 00 5952 020 10 00 5952 020 12 00 5952 020 14 00 5952 020 17 00 5952 020 20 90 5952 020 17 90 5952 020 20 00 5970 020 09 00 5970 020 10 00 5970 020 12 00 5970 020 14 00 5970 020 17 00 5970 020 20 90 5970 020 09 90 5970 020 10 90 5970 020 12 90 5970 020 14 90 5970 020 17 90 5970 020 20 Micro Articular Surfaces Purple Femur A B Tibia 1 2 NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 17mm Height
2. Do not use standard size patellas with A B micro size femoral components Cronk t japan only Figure 1 NexGen CR Compatibility Chart The approved combinations are driven by differences in the condylar bearing spaces The standard CR femur and articular surfaces have a condylar bearing space of 44 mm while the CR micro femur and articular surfaces have a condylar bearing space of 36 mm Risks An incompatible combination of articular surface and standard femoral component may lead to higher contact stresses at the medial and lateral edges of the articular surface Therefore Zimmer has determined that using standard and micro components in an incompatible combination could potentially lead to the following risks e The immediate risk could be that the knee cannot be properly balanced thereby potentially leading to long term pain and instability e The long term risk of using a micro articular surface with a standard size femoral component could be increased wear of the polyethylene which may lead to pain osteolysis tibial loosening instability and revision surgery Edge Loading Analysis Loading at the edge of the tibial polyethylene surface condition is much more prevalent in size combinations where the femoral component overhangs the articular surface As the tibial plate and articular surface size increases the amount of femoral component overhang decreases and loading at the edge of the tibial polyethylene surface is much les
3. Page 2 of 2 March 16 2012 To Surgeons using the NexGen Cruciate Retaining CR Micro Articular Surface Components Subject URGENT CORRECTIVE ACTION NOTICE Affected Products See attached list Tables 1 amp 2 ZIMMER NEXGEN CRUCIATE RETAINING CR MICRO ARTICULAR SURFACE COMPONENTS Dear Surgeon The purpose of this notification 1s to inform you of an implant component compatibility issue with the NexGen Cruciate Retaining CR Complete Knee System how to prevent the issue and what to do with patients who may have been implanted with an incompatible component combination Zimmer has received complaints where a NexGen CR micro articular surface was used with a standard CR femur even though the compatibility chart indicates that these combinations are NOT approved CR micro articular surfaces are used in approximately 2 2 of all NexGen CR procedures It is believed that a CR micro articular surface and standard femoral component combination may have been used in some of those procedures It is important to note however that there have been no reported failures due to this situation You are receiving this letter as a user of the NexGen CR System to ensure you refer to the compatibility chart and labeling and to make certain you are aware of the correct use combinations of CR micro articular surfaces with standard CR femoral components The part numbers of the CR micro articular surfaces are listed on the last pages of this
4. Product Unaffected by the Recall Product with a blue dot on the carton has been inspected and is unaffected by the recall If you receive product with a blue dot you do not need to return it The photo to the right shows what the blue dot looks like and where it is located on each carton The Medicines and Healthcare Products Regulatory Agency has been informed of this recall Yours sincerely e Tony Horn Quality amp Regulatory Manager Advanced Surgical Devices UK Ireland gt We are smith amp nephew DECLARATION Smith amp Nephew Advanced Surgical Devices Endoscopy metal and peek suture anchors Fax to Smith amp Nephew Endoscopy on 01480 423241 Please return this declaration by 31 August 2012 can confirm that have the following numbers of affected items in our stock please include a zero in the quantity column if your stock is nil Product Code 24 Quantity Cont Product Code it Quantity Where applicable these have been segregated awaiting shipping and return instructions from Smith amp Nephew Product Services Department who have been contacted regarding this matter Signed Print Name Position Organisation Hospital Date gt We are smith amp nephew DECLARATION Cont Product Code 24 Quantity Cont Product Code ft Quantity Where applicable these have been segregated awaiting shipping and return instructions from Smith amp Nephew Product Servic
5. The lead can become entangled with or erode into the bowel which can result in bowel obstruction and or perforation Either may lead to life threatening intra abdominal infections and may require laparotomy bowel resection and system revision Avoid excess lead slack in the abdominal cavity Post implant consider lead entanglement or erosion as a possible etiology in patients with bowel obstruction symptoms Patient Manual Page 1 of 3 Bowel Entanglement The Enterra wires can become entangled with your bowel and cause life threatening blockage or infections that require immediate medical attention and may require surgery Contact your doctor if you have new or unusual abdominal pain cramping nausea or vomiting at any time after surgery Hecommendations Medtronic does not recommend prophylactic replacement of the Enterra system due to the estimated low occurrence rate 0 4 Note this is a therapy related issue and is not related to the quality of the product If a patient is experiencing signs and symptoms of bowel obstruction or perforation they should contact their health care provider Laparotomy bowel resection system revision or other interventions may be required if itis determined that the patient has bowel obstruction and or perforation related to Enterra therapy Review the Enterra Therapy Model 4351 Lead Technical Manual and the Enterra Therapy Model 3116 Gastric Electrical Stimulation Svstem Technical Manual
6. Therefore please identify all Ultrasound Adapter BK Medical 8862 8863 Article number 41860 35 and remove them from clinical use The article number 41860 35 is engraved on the metal part of the adapter please refer to Figure 2 You will be provided with a replacement accordingly All other Brainlab Navigation functionalities remain unaffected and can be used Figure 2 Identify the affected adapter Ultrasound Adapter BK Medical 8862 8863 including detail view of engraved article number 41860 35 FORM 14 04 CAPA 20121129 000146 Rev 7 Page 2 of 3 A BRAINLAB Brainlab Corrective Action 1 Existing potentially affected customers receive this product notification letter 2 Brainlab will actively provide revised hardware to correct this error Tentative planned timeline for availability Mid of March 2013 Please advise the appropriate personnel working in your department of the content of this letter We sincerely apologize for any inconvenience and thank you in advance for your co operation www brainlab com If you require further clarification please feel free to contact your local Brainlab Customer Support Representative Customer Hotline 49 89 99 15 68 44 or 1 800 597 5911 for US customers or by E mail support brainlab com Fax Brainlab AG 49 89 99 15 68 33 Address Brainlab AG headquarters Kapellenstrasse 12 85622 Feldkirchen Germany December 5 2012 Kind Regards C Julia Mehltretter
7. 00 5972 020 20 00 5976 020 10 00 5976 020 12 00 5976 020 14 00 5976 020 17 00 5976 020 20 00 5970 020 23 00 5972 020 23 00 5976 020 23 NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 9mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Purple 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Purple 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Purple 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Purple 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Purple 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 23mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 23mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Purple 23mm Height Zimmer Table 2 Part Number 00 5952 031 10 00 5952 031 12 00 595
8. CooperSurgical roept vrijwillig de UMH700 RUMI ARCH en bepaalde versies van de UMH750 handgrepen Advincula ArchTM terug De UMH700 was eerder dit jaar uit het assortiment genomen en werd vervangen door de Advincula Arch UMH750 handgreep Reden voor deze veldactie I RUMI Arch Advincula Arch UMH 700 UMH 750 Cleaning Hole gt n eb IN T DP Cleaning Hole Serial Number Serial Number Als er teveel druk wordt uitgeoefend op het baarmoederuiteinde als dat wordt vastgemaakt aan de boog kan dat er in bepaalde omstandigheden voor zorgen dat de interne stalen draad van het uiteinde het reinigingsgat van de schacht van de handgreep doorboort Instrumenten die worden teruggeroepen Onderdeelnummer Productomschrijving Details UMH700 RUMI ARCH ALLE handgrepen moeten worden teruggestuurd UMH750 Advincula Arch Enkel de handgrepen met een serienummer lager dan 1204001 of tussen 11110010 en 11110069 moeten worden teruggestuurd Uit onze gegevens blijkt dat een of meer van deze instrumenten naar u werden verzonden Neem contact op met al uw klanten die over deze instrumenten beschikken en laat ze zo snel mogelijk vervangen Neem contact op met onze klantendienst op 203 601 9818 Druk bij de eerste keuzemogelijkheid op 1 Druk bij de tweede keuzemogelijkheid opnieuw op 1 Er zullen regelingen worden getroffen om uw product te vervangen op kosten van CooperSurgical U zult dan rechtstreeks verdere instructies en informat
9. Facility Name Department Telephone Date Signature Hopital Nom Chef de Pharmacie Rue Code Place Diegem 3 december 2012 Ref FMJRI 12 389 ASP05 2012 AVIS DE S CURIT RAPPEL DE PRODUITS Indicateur biologique STERRAD CycleSure 24 Ch re Madame cher Monsieur Type de dispositif Le probl me concerne les codes produits et num ros de lot suivants REF 14324 Indicateur biologique STERRAD CycleSure 24 REF 14325 Kit de test STERRAD CYCLESURE 24 REF 20239 Kit de test STERRAD NX REF 20243 Kit de test international STERRAD 100NX REF 20123 Kit de test cyclique STERRAD 100NX EXPRESS REF 20232 St rilisateur STERRAD 50 1005 Kit de validation CYCLESURE 24 REF 20233 St rilisateur STERRAD 200 Kit de validation CYCLESURE 24 REF 20253 Kit de validation STERRAD NX REF 20228 Kit de validation STERRAD 100NX REF 20248 Kit de validation cyclique STERRAD 100NX EXPRESS Num ros de lots tous les num ros de lots qui ont t fabriqu s entre f vrier 2008 et d cembre 2011 Probl me Il se peut que la date de p remption ne soit pas conforme la documentation d ASP Advanced Sterilization Products ASP a r cemment d termin qu il ne disposait pas de donn es suffisantes pour confirmer la dur e de conservation du produit en stock et figurant sur l tiquette du produit Par cons quent ASP demande ses clients de faire l inventaire de leur approvisionnement d indicateurs biologiques IB STERRAD CYCLESURE 24
10. Field Safety Corrective Actions FSCA regarding LED battery insert for HEINE Standard F O Laryngoscope Handle with LED illumination Attention Medical device dealers distributors responsible personnel for medical devices Hospital Administration Department of medical devices Anesthesia Details on affected devices LED battery insert without bottom cap HEINE catalogue number REF F 008 22 890 SN 1230009124 serial number HEINE LED Laryngoscope battery Insert This corrective action affects all LED battery inserts with serial numbers in the range of 1230000000 and 1230999999 The affected devices were manufactured in the time period from February 12 2010 to September 15 2011 LED battery inserts whose serial number begins with 1231 or 1232 are not affected by this corrective action Please note that the LED battery insert was delivered both as an individual item and as part of the following articles Catalogue Number Catalogue Number Article Description Article Description STAND F O LED LARYN GR 2 5V F 008 22 860 FLEXTIP LED LARYNGOSC SET FT3 F 227 28 865 STAND F O LED LARYN GR 3 5V F 008 22 863 F O LARYNG SET MAC MODULAR F 228 18 860 LED BATT EINSCHUB F STAND F O F 008 22 890 F O LARYNG SET MAC MODULAR F 228 28 865 HRA 52 039 M nchen Heine Optotechnik Verwaltungs GmbH Herrsching HRB 45192 M nchen Gesch ftsf hrer Dipl Kfm Helmut M Heine Oliver Heine BA WEEE Reg
11. LED concern jusqu l change de l appareil il vous sera alors indispensable d avoir votre disposition d autres mesures de s curisation des voies respiratoires que vous pourrez imm diatement utiliser si n cessaire Veuillez cet effet r aliser un contr le de HRA 52 039 M nchen Heine Optotechnik Verwaltungs GmbH Herrsching HRB 45192 M nchen Gesch ftsf hrer Dipl Kfm Helmut M Heine Oliver Heine BA WEEE Reg Nr DE 87119271 1 5 201 2 02 15 FR FSN docx Interne ID 15 2012 02 16 FR FSN HEINE HEINE Optotechnik GmbH amp Co KG Kientalstr 7 82211 Herrsching Germany Tel 49 0 8152 38 0 Fax 49 0 81 52 38 202 E Mail info heine com www heine com fonctionnement du laryngoscope avant chaque utilisation l clairage du boitier piles LED ne doit pas s teindre apr s l avoir fortement secou ou apr s un mouvement rotatif rapide b Utilisation avec des piles rechargeables HEINE accumulateur sp cial rechargeable o Veuillez contacter votre revendeur ou fournisseur afin que celui ci puisse proc der un change gratuit o Aucun incident ne nous a jusqu pr sent t rapport dans le cas d une utilisation de la LED avec des piles rechargeables HEINE Vous pouvez donc encore utiliser l appareil en toute s curit jusqu son change Diffusion des informations d crites dans ce document Veuillez vous assurer dans votre tablissement que tous les utilisateurs du prod
12. MEDICAL Telefiex Medical Stirling Road Cressex Business Park High Wycombe HP12 3ST England Phone 44 051494 532761 Fax 44 0 1494 524650 11 August 2009 Urgent Field Safety Notice Commercial Name of Affected SHERI I SWIV Product SHER I BRONCH Type ofaction un Dear Customer 1 Details on affected devices Teleflex Medical has issued a voluntary recall for the specific catalog numbers and date range of the SHER I SWIV and SHER I BRONCH as shown in the table below Affected batch numbers are listed in Appendix A of this field safety notice Catalog Number Description gt 5 Date Range _5 15401 516028 ET Tube Sher 1 Bronch LS 28FR ET Tube Sher I Bronch LS 37FR ET Tube Sher I Bronch LS 41FR ET Tube Sher i Bronch RS 28FR n i ET Tube Sher I Bronch RS 39FR ET Tube Sher I Bronch RS 41FR EB Tube Sher I Bronch LS 35FR Nova Plus EB Tube Sher I Bronch LS 37FR Nova Plus Meleflex MEDICAL Catalog Number V5 16039 EB Tube Sher I Bronch LS 39FR Nova May 1 2004 through Plus May 31 2009 Plus 2 Description of the problem Teleflex Medical has determined that the tether attaching to the double swivel cap may partially or completely break at the attachment points The broken tether may lodge inside the dual swivel tubing or body during shipment to the end user resulting in the potential for the accidental aspiration of the tether into the
13. r ception d un nouveau Guide corrig Nous vous remercions de bien vouloir transmettre vos patients trait s domicile une copie de ce courrier Nous vous remercions de bien vouloir compl ter le formulaire joint ce courrier et de le retourner par fax Baxter au num ro indiqu sur le formulaire Le retour rapide de ce formulaire r duira la probabilit des relances Un guide corrig sera mis et envoy aux clients qui auront recu le guide avec les erreurs de traduction Nous vous remercions par avance de votre coop ration et restons votre enti re disposition pour vous fournir toute information n cessaire que vous jugeriez utile d obtenir Nous vous prions de bien vouloir recevoir Madame Monsieur l assurance de nos consid rations distingu es Pascal Pollet CQA Manager France Benelux Pharmacien responsable Baxter Belgium Sprl Tel 32 68 27 28 15 Fax 32 68 27 27 42 Mob 32 478 50 34 21 email pascal pollet baxter com FCA 2012 003 RN HomeChoice error in French manual Baxter FORMULAIRE DE R PONSE CLIENT Lettre importante d information Produit en date du XX Avril 2012 Systemes de DPA HOMECHOICE et HOMECHOICE PRO Guide du Patient Domicile 07 19 64 016FRE Compl ter et renvoyer ce formulaire au num ro de FAX suivant Fax 068 27 27 42 ou de l envoyer pas email complaint beneluxQbaxter com Une page de couverture n est pas n cessaire VOTRE RAPIDE RETOUR EVITERA LES
14. Advanced Sterilization Products ASP a r cemment d termin qu elle ne disposait pas des donn es suffisantes pour soutenir l int gralit de la dur e de conservation en stock figurant sur l tiquette du produit Par cons quent ASP demande ses clients de faire l inventaire de leur approvisionnement d indicateurs biologiques IB STERRAD CYCLESURE 24 et de contr ler chaque cas par rapport la dur e de conservation en stock r vis e du produit en suivant les instructions fournies dans la section Quelle action est requise ci dessous Tous les clients doivent arr ter d utiliser les produits issus des lots d indicateurs biologiques IB STERRAD CYCLESURE 24 qui d passent la date de p remption nouvellement d finie et renvoyer le s produit s concern s L utilisation d un produit p rim risque de rendre la v rification de conditions de st rilisation ad quates impossible Action Nous avons besoin de votre aide pour nous assurer que tous les produits concern s sont localis s et trait s conform ment aux instructions suivantes ENTR E EN VIGUEUR IMM DIATE Contr lez la date de p remption imprim e sur l emballage des composants de l indicateur biologique IB STERRAD CYCLESURE 24 comme le montre la Figure 1 et consultez le tableau joint l Annexe 1 qui r pertorie chaque num ro de lot concern la date de p remption actuelle sur l tiquette et la nouvelle date de p remption calcul e par conversion
15. Brief van 10 augustus 2012 V Y H IM RR mw P1122 Archiefbeelden betroffen door deze storing kunnen niet meer gecorrigeerd worden Wanneer dergelijke beelden in plaza geopend worden worden de incorrecte metingen als volgt aangeduid niet van toepassing als deze beelden naar andere DICOM viewers gestuurd worden Wij verzoeken u vriendelijk om onmiddellijk uw personeel hierover in te lichten en deze brief toe te voegen aan de bedieningshandleiding van uw systeem zodat de gebruikers hiermee rekening houden totdat de update uitgevoerd is Indien u dit systeem hebt verkocht en het niet langer in uw bezit is verzoeken wij u om deze veiligheidsinformatie door te sturen naar de nieuwe eigenaar Gelieve ons in dit geval ook mee te delen wie de nieuwe eigenaar van dit systeem is Wij danken u voor uw begrip en medewerking Hoogachtend Siemens naamloze vennootschap Rob Reijn Stefaan De Moor Service Modality Manager Service Director Blz 2 van2 Zimmer GmbH Box CH 8404 Winterthur Phone 41 0 52 262 60 70 zimmer Fax 41 0 52 262 03 64 www zimmer com Urgent Field Safet Notice Product Name Patient Labels for Zimmer Products manufactured prior to March 2010 FSCA identifier FA 2012 01 Type of action Notification Date 6 August 2012 Attention Trust Chief Executives Clinical Director Orthopaedic Department Orthopaedic Theatre Manager Safety Liaison Officer General Manager Private Sector Typ
16. Deze kennisgeving moet naar iedereen verzonden worden die hiervan op de hoogte moet zijn binnen uw organisatie of naar elke organisatie waar de potentieel getroffen apparaten naar overgebracht kunnen zijn Omdat u dit product gedistribueerd heeft verzoeken we uw hulp om Midmark te voorzien van de namen en adressen van uw klanten die een van de bovenvermelde modelnummers hebben gekocht Neemt u a u b contact op met de afdeling Technische Dienst van Midmark Midmark s Technical Service om vast te stellen wat de beste manier is om de contact informatie te geven Indien u deze corrigerende praktijk actie intern wilt uitvoeren laat u dit dan aan Midmark weten dan kunnen we u van de nodige labels voorzien en kopieen van een kennisgeving die gelijk is aan deze zodat uw klanten deze corrigerende praktijk doeltreffend kunnen begrijpen en doorvoeren door het correct aanbrengen van de nieuwe waarschuwingslabels op hun eenheden Wij stellen uw medewerking in het doorvoeren van deze corrigerende praktijk zeer op prijs Het extra waarschuwingslabel wanneer het juist is aangebracht zal het voortdurend veilig en effectief werken van Midmark producten bevorderen Indien u vragen heeft belt u dan de afdeling Technische Dienst van Midmark Midmark s Technical Service op 1 937 526 2649 Omdat we het goed willen doen d Tim Taylor Directeur Kwaliteit Midmark Corporation Bijlage n Instructies om het label aan te brengen Waarschuwingslabel
17. NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 9mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 9mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Purple A E Micro 20mm Height Part Number 00 5972 020 09 00 5972 020 10 00 5972 020 12 00 5972 020 14 00 5972 020 17
18. TENCKHOFF T201 X1 TENCKHOFF T202 Q X1 COLLCATH C CA2 X1 COLLCATH C CAT X1 SWANNECK SN T2 LT X1 SWANNECK SN T2 RT X1 SWANNECK SN T2 LONG LT X1 SWANNECK MISS SN M2 LT X1 SWANNECK MISS SN M2 RT X1 SNROZ TW H2 LT Xi SN LSN OZ TW H2 RT X1 Page 1 ATTACHMENT A Beta Cap Adapter09 12 8888413100 Peritoneal Dialysis Catheter INFANT SWAN NECK CURL CATH 38 9CMX1 Page 2 Mechelen 5 octobre 2012 Information relative a la s curit Adaptateur pour cath ter de dialyse p riton ale Beta Cap Madame Monsieur Covidien souhaite vous informer d une alerte relative l utilisation de l adaptateur pour cath ter de dialyse p riton ale Beta Cap r f rence produit 8814 661001 avec les dispositifs de transfert Baxter r f rences produits 5CA325 5C4482 5C4483 R5C4484 and 5C4449 En effet il a t constat un probl me de filetage entre l adaptateur et le dispositif de transfert de Baxter Ce probl me de filetage pourrait augmenter les risques de s paration et causer une p ritonite Nous avons t inform s par Baxter qui recommande de ne pas utiliser ces deux dispositifs ensemble Dans l ventualit o les dispositifs de Dialyse P riton ale list s dans le document joint tous ceux contenant l adaptateur BETA CAP Quinton devraient tre utilis s avec le dispositif de transfert Baxter nous recommandons que l utilisateur prenne toutes pr cautions pour s assurer
19. a Bei Betrieb mit Trockenbatterien o Setzen Sie sich f r einen kostenlosen Austausch mit Ihrem H ndler bzw Lieferanten in Verbindung o Stellen Sie in Ihrer Organisation sicher dass die LED Batterieeinsch be nicht mehr verwendet werden o Kann auf die Verwendung des Laryngoskops mit einem betroffenen LED Batterieeinschub bis zum Austausch nicht verzichtet werden halten Sie unbedingt alternative Ma nahmen zur Atemwegssicherung bereit die Sie beim Ausfall des Laryngoskops unmittelbar einsetzen k nnen F hren Sie zudem vor jedem Einsatz des Laryngoskops eine Funktionskontrolle durch Das Licht des LED Batterieeinschubs darf auch bei kr ftigem Sch tteln oder einer schnellen Rotationsbewegung nicht ausgehen Interne ID 15 2012 02 15 DE FSN HEINE b Bei Betrieb mit HEINE Ladebatterien spezielle wieder aufladbare Akkus o Setzen Sie sich f r einen kostenlosen Austausch mit Ihrem H ndler bzw Lieferanten in Verbindung o Uns sind bisher keine Ausf lle beim Betrieb des LED Batterieeinschubs mit HEINE Ladebatterien bekannt Sie k nnen das Ger t bis zum Austausch sicher weiter verwenden Weitergabe der hier beschriebenen Informationen Bitte stellen Sie in Ihrer Organisation sicher dass alle Anwender der oben genannten Produkte und sonstige zu informierende Personen Kenntnis von dieser Dringenden Sicherheitsinformation erhalten Sofern Sie die Produkte an Dritte abgegeben haben leiten Sie bitte eine Kopie dieser Infor
20. hereby confirm that organisation has received the important safety message from Silentia dated 2012 06 26 and circulated it as instructed Name title Location date Please email fax or post this page to Silentia AB Email qc silentia se Fax 46 0 346 485 89 Address Silentia AB Box 108 SE 311 22 Falkenberg Sweden SILENTIA AB Box 108 SE 311 22 Falkenberg Sweden Tel 46 0 346 485 80 Fax 46 0 346 485 89 infoasilentia se www silentia se Org nr 556114 6902 3 3 Hopital Nom Chef de Pharmacie Rue Code Place Diegem 6 juillet 2012 Ref FMJR 12 194 AVIS DE S CURIT Indicateur biologique STERRAD CycleSure 24 Ch re Madame cher Monsieur Type de dispositif Le probl me concerne les codes produits et num ros de lot suivants REF 1414324 Indicateur biologique STERRAD CycleSure 24 REF 14325 Kit de test STERRAD CYCLESURE 24 REF 20239 Kit de test STERRAD NX REF 20243 Kit de test international STERRAD 100NX REF 20123 Kit de test cyclique STERRAD 100NX EXPRESS REF 20232 St rilisateur STERRAD 50 1008 Kit de validation CYCLESURE 24 REF 20233 St rilisateur STERRAD 200 Kit de validation CYCLESURE 24 REF 20253 Kit de validation STERRAD NX REF 20228 Kit de validation STERRAD 100NX REF 20248 Kit de validation cyclique STERRAD 100NX EXPRESS Num ros de lot concern s voir annexe 1 Probl me Il se peut que la date de p remption ne soit pas prise en charge par la documentation d ASP
21. pM M NW NEN E DEN FEN ne HEREIN E Bu EET A A A ee m GE AE AA e EEE nm Ba ro po Zu u E I AE EE ob TER nl Eq es MES Eq ues A baies A SU E MNT GE FR Ei EEE EEE lod AA A rr TEN FEE PE DE an 2H NOA bo er E EE EE EE EE WE B ODOREM RE KC FETE A LLL B GE NE RCI lea AND 101 t9 AD 101 ee AD 107 88 AD HIT es AD 191 ampara ano D Tomemos omen Tonos JequinN UONEZUOUINY VINO y JO yuewsse das 10 3onpo d Jepuss pues 7 Jo onpoud juetus9e de pues ouo 199 95 eseejd espe 1 Aq paea sl 12npoud sy YoU SEND BuImojior Su wma IM pue 3onpoud PSJOSHE au egel SIU paunuejenb SAM uonnquisip pue asn panunuoosip Ayers Jno je jonpoud pejoege Bujwojay au SM 40 edoos y urypm eM 7 SAOGE JSQUINU sy Xe Ag WLIO Siy unya pue ejeudoudde su x2suo asead HINOJO PAUTAS PUR NIMS I H3HS D2HON Ajejes pjalg paysenbay uonushy ejerpoautui 0S9vZS v6ri 0 vr XA 83iAI9S JEWIOJISNI OL WHOd SNLVLS MOOLS ANY LNANIDGITMONMIVY TIVIA 1YIIGSW g XidN3ddV x3 1J313 L junoose ino ppap 7 Quse August 2009 Urgent Field Safety Notice Patient Safety Information Enterra Therapy Gastric Electrical Stimulation System Lead Models 4351 4300 4301 and Stimulator Models 3116 7425 Medtronic Reference FA441 This let
22. tre respect e afin que nous ayons la certitude que la totalit des dispositifs potentiellement concern s aie t mise en conformit L apposition de ce sticker additionnel constitue une action corrective de s curit d cid e en accord avec la FDA the Food and Drug Administration et les diff rentes autorit s comp tentes europ ennes En tant que distributeur de ce s produit s nous sollicitons votre aide pour obtenir les noms et adresses de vos clients utilisateurs des st rilisateurs des mod les list s ci dessus Nous pourrons ainsi leur envoyer le sticker d avertissement les instructions de pose ainsi que le formulaire nous retourner renseign Nous aurons ainsi la certitude d avoir men cette action jusqu aux utilisateurs finaux Merci de contacter le service technique de Midmark Midmark s Technical Service pour d terminer la meilleur facon de nous communiquer ces informations Si vous souhaitez proc der vous m mes cette intervention merci d en informer Midmark qui mettra votre disposition les stickers et documents n cessaires A l instar des utilisateurs finaux nous vous demanderons de nous confirmer par retour la r alisation effective de cette intervention Nous comptons tr s sinc rement sur votre collaboration Pour toute question n h sitez pas contacter Midmark par mail l adresse suivante fieldcorrection midmark com ou par t l phone au Midmark s Technical Service department au 1 8
23. 14 2011 may be affected Initial and Final Strut values are correct only the duration of the strut adjustment schedule can be affected The issue has been corrected Risks to Health In the worst case if the extended strut adjustment schedule goes unnoticed the bone may consolidate sooner than anticipated and may require additional surgery Actions to be 1 Review unfinished procedures based on schedules prepared with the SpatialFrame com taken by the user Software If there appear to be unexpectedly long strut adjustment schedules open and reprint the schedules Page 1 2 Smith amp Nephew Orthopaedics AG T 41 0 62 832 06 06 adi 2 Schachenallee 29 41 0 62 832 06 07 ar smith amp nephew 5001 Aarau www smith nephew com Switzerland 2 Acknowledge receipt of the notification you received by e mail or complete the below return slip and fax it to your national Smith amp Nephew agency distributor 3 Please make sure this safety information is passed on to all those who need to be aware of it within your organization 4 Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of the action Other In Europe this field action of Smith amp Nephew Inc Memphis US is coordinated by Smith Information amp Nephew Orthopaedics AG Smith amp Nephew is committed to distribute only products of the highest quality standard
24. 24 26 e mail quality olympus be Functie Departement Ziekenhuis stempel van uw organisatie otraat otad Contactpersoon Materiovigilantie Tel e mail Handtekening OLYMPUS BELGIUM N V Boomsesteenweg 77 B Zb ll Aartselaar Tel 32 0 3 870 08 O Fax 32 0 3 887 24 25 www olympus be Deutsche Bank Brussels 826 0004292 41 IBAN BE88 8260 0042 8241 BIC DEUTBEBE RPR RPM Antwerpen B T W T V A BED400 804 002 Life wath Robotic Precision and Sater URGENT FIELD SAFETY NOTICE To Stereotaxis Customers with access to V CAS and V CAS Deflect From Michael Craven Senior Director Product Marketing Date 2 1 2013 Re Potential patient hazard V CAS Catheter Advancement System Order 001 002422 1 and V CAS Deflect Order 4 001 003054 1 controlled by NAVIGANT software versions 4 0 through 4 3 0 Dear Stereotaxis Customer A potential patient safety hazard has come to our attention related to magnetic catheter advancement on the Vdrive While Stereotaxis is not aware of any instance of the hazard occurring in a clinical patient situation we are proactively communicating and addressing the issue e The observed hazard The V CAS and V CAS Deflect catheter advancement systems are designed to advance and retract compatible RMT catheters using the Vdrive robotic system In our testing facility we recently observed a situation where the knob of a Vdrive controll
25. MDR amp Vigilance Manager brainlab vigilance brainlab com Europe The undersign confirms that this notice has been notified to the appropriate Regulatory Agency in Europe FORM 14 04 CAPA 20121129 000146 Rev 7 Page 3 of 3 Hospira 29 October 2012 URGENT FIELD SAFETY NOTICE ALL HOSPIRA PLUM A SINGLE CHANNEL FAMILY OF INFUSERS Volume Knob Rotation Plum A Single Channel Family of Infusers 11005 Plum A Hyperbaric infusion system 11971 12391 Plum A single channel infusion system 20792 Plum A infusion pump with Hospira MedNet software Q FA EMEA 2012 014 29 October 2012 Dear Healthcare Professional and Hospira Customer Hospira Inc is issuing this Field Safety Notice to inform you that the volume control knob on some Plum A single channel infusers located on the back of the infuser may not function as described in the System Operating Manual the direction for Loud and Quiet may be reversed The manual indicates a clockwise rotation of the knob decreases the volume however on some of the devices the alarm volume increases when the knob is turned clockwise In the event the healthcare professional rotates the volume control knob in the direction described in the System Operation Manual the audible tone may be the opposite of the desired audio level While the device will continue to alarm with an audible tone of at least 50 dBA at the lowest level inadvertently setting a low ton
26. Number Still in your warehouse Still in your Customer stock 0003065579 0143065579 _ Already used by customer Still in your warehouse n la Still in your Customer stock 0003065580 0143065580 Already used by customer Still in your warehouse onn ln Still in your Customer stock 0003065601 0143065601 Already used by customer Still in your warehouse m n _ Still in your Customer stock 0003065602 0143065602 Already used by customer _ Still in your warehouse m mm Still in your Customer stock 0003065603 0143065603 Already used by customer Polysite ECHO kit Serial Number Notification Receipt date 1 Please complete this inventory sheet whenever you do not have on stock in your facility 2 Please send it back by fax on 33 0 3 44 08 17 17 or by e mail s vide perousemedical com by October 12 2012 Polysite Status of the product Serial Number Still in your warehouse Still in your Customer stock _ Already used by customer Still in your warehouse Still in your Customer stock Already used by customer C Still in your warehouse Still in your Customer stock Already used by customer Still in your warehouse Still in your Customer stock Already used by customer Still in your warehouse Still in your Customer stock Already used by customer Thank you for your help
27. Ref 50038347 Batch LOT Quantity Quarantined pieces trays IO E A NAME POSITION EMAIL ADDRESS SIGNATURE DATE HOSPITAL INSTITUTE COUNTRY HOSPITAL CONTACT TELEPHONE NUMBER Page 2 of 2 Field Safety Notice Attention Date ascom Ascom Sweden AB Wireless Solutions P O Box 8783 402 76 G teborg Customers with Ascom Mobile Monitoring Gateway MMG and Cardiomax 10 July 2012 Field Safety Notice related to a Medical Device System Installation Dear Customer Ascom Wireless Solution wishes to bring to your attention the following information which has also been communicated to the Competent Authority in your country EU USA and CAN Details on affected devices Ascom Mobile Monitoring Gateway MMG Ascom Cardiomax The anomaly is located in the MMG and Cardiomax software MMG FE3 D1ABAA and FE3 D1ABAB software version 2 01 Cardiomax FE3 G1ABAB software version 3 1 0 and earlier Description of the problem When assignments are changed for a location the location conditions are stored in a memory cache however these entries are not deleted Eventually the memory cache becomes full which results in a module reboot During this time no information is communicated to any display devices Advise on action to be taken at the customer Ascom has resolved the anomaly and has developed verified and validated a solution Your local Ascom Wireless Solutions representative will conta
28. Suivre particuli rement les instructions d taill es de pr nettoyage en particulier pour l extr mit distale et l recteur Afin de vous aider dans ces pr conisations veuillez trouver ci joint un descriptif des actions a mener Ce document doit tre consid r comme une information compl mentaire aux instructions de traitement d crites dans le manuel d entretien De plus nous vous rappelons que TJF Q180V comme tous les endoscopes Olympus doit faire l objet d une pr paration et d une inspection minutieuses avant utilisation sur un patient Au cas vous constateriez un d faut ou un dysfonctionnement l endoscope ne pas tre utilis et nous vous recommandons de contacter Olympus pour un contr le et une r paration ventuelle L utilisation d un endoscope qui ne fonctionne pas correctement peut compromettre la s curit et la sant de l op rateur ou du patient et peut entrainer des dommages plus graves au dispositif m dical Pour plus d informations sur les tapes requises veuillez vous r f rer au chapitre 3 Pr paration et inspection du manuel d utilisation du TJF Q180V Des copies suppl mentaires du manuel d instructions ou du manuel de traitement sont disponibles sur demande Merci de transmettre cette lettre d information toutes les personnes concern es au sein de votre tablissement Nous sommes convaincus que l information ci jointe peut vous servir Nous restons votre disposition pour vous donner
29. Technische Dienst Bulletin Product Dienst Leven Retour Antwoordformulier Instructies om het label aan te brengen 1 Zorg ervoor dat de oppervlakte waar het label op geplakt wordt droog en schoon is 2 Haal de achterkant van de kleefkant van het label af en plaats het label op het gebied dat is aangegeven naast de deurhendel 3 Wrijf het label er stevig op om ervoor te zorgen dat het goed op de eenheid vastgeplakt is WAARSCHUWING Laat de Sterilizer nietwerken wanneer de deur niet volledig vergrendeld is De vergrendelingshendel dient vlak met de deur te liggen Indien de deur niet volledig vergrendeld is kan dit tot ernstig letsel leiden gt CORRIGERENDE PRAKTIJK ACTIE FIELD CORRECTIVE ACTION RETOUR ANTWOORDFORMULIER Getroffen M11 Steam Sterilizer Modelnummers M11 001 M11D 001 M11 001R M11 002 M11D 002 M11 002R M11 003 M11 004 M11 005 en M11 006 Vink a u b ALLE toepasselijke vakjes aan Ik heb de corrigerende praktijk actie gelezen en begrepen die in de brief van 9 januari 2012 werd gegeven Ik heb het label op de sterilisator s aangebracht Noteer het de serienummer s hieronder Geef de aard van de corrigerende praktijk actie van het de product en aan Noteer het de serienummer s hieronder de eenheid is niet meer in gebruik specificeer de datum dat de eenheid uit dienst werd genomen de eenheid is verhandeld specificeer de datum dat de eenheid werd ve
30. after power cycle Device functions as 2 22200 intended once user settings are configured or verified after power cycle there is no impact to performance Affected Product Rad 8 devices that are used with custom configured settings Impact Assessment The directions for use for the Rad 8 device indicate that user settings shall be verified at each use If the end user fails to verify user settings after a power cycle it is possible that an end user may unintentionally monitor a patient with a Rad 8 device that has reverted back to factory default settings which may or may not be appropriate for the patient s clinical condition Action to be Taken If your unit is used with custom configured settings please take one of the following two actions 1 Verify functionality of your device using the instructions provided in the URL below If your device has successfully passed ail instructions your device is not affected by this notification and you may resume use URL http www masimo com training rad8 OR Masimo Technical Services will guide you through a comprehensive screen via phone to determine whether or not your device 1s affected by this notice 2 if your device did not pass the screening please discontinue use of the device in use case scenarios where custom settings are required Contact Technical Services to obtain a free software upgrade which will restore user default retention functionality of your device This upgr
31. diminution de la date de p remption imprim e de neuf 9 mois pour v rifier la date de p remption correcte DTI Location Lot Number Expiration Date Si vous d couvrez que certains de vos indicateurs biologiques STERRAD CYCLESURE 24 sont p rim s le produit p rim doit tre retourn imm diatement selon les Instructions de retour du produit figurant ci dessous ASP vous recommande fortement de r tiqueter manuellement les produits non p rim s avec la nouvelle date de p remption calcul e de mani re ce que votre stock soit correctement tiquet pour tre utilis Voir le tableau de conversion l Annexe 1 Marche suivre pour retourner les produits 1 Examinez votre stock et retournez tous les indicateurs biologiques IB STERRAD CYCLESURE 24 inutilis s qui ont d pass la nouvelle date de p remption d finie 2 Comptez physiquement votre stock de produits ayant d pass la nouvelle date de p remption d finie et consignez les donn es sur le Formulaire de r ponse 1 Remplissez le Formulaire de r ponse et retournez le fax 02 746 3001 dans un d lai de 3 jours ouvrables m me si vous ne poss dez pas les produits concern s Si vous avez des produits retourner conservez un exemplaire de ce formulaire pour vos dossiers 2 Pour retourner un produit concern joignez un exemplaire du Formulaire de r ponse au produit Votre repr sentant se tient votre disposition pour vous
32. for appropriate implant techniques warnings and patient management instructions Avoid excess lead slack in the abdominal cavity during implant Post implant consider lead entanglement or erosion as a possible etiology in patients with bowel obstruction and or perforation symptoms Remind patients to contact their doctor if they develop signs or symptoms of bowel obstruction and or perforation Additional Information The Competent Authority of your country has been notified of this action We are committed to answering your questions and keeping you informed Medtronic continues to investigate this issue and will provide vou with an update if our recommendations change This notice needs to be passed on all those who need to be aware within your organization If you have questions please contact your Medtronic field representative countries to edit or contact Medtronic European Technical Services at 31 45 566 8844 This important patient management information is also available at http www professional medtronic com under the heading Advisories Sincerely XXXXX Country Manager Page 2 of 3 VNAO URGENT FIELD NOTIFICATION December 22 2010 BY FEDERAL EXPRESS Name Address Attn Biomedical Clinical Engineering Departments Re Inability to retain user default settings on Rad 8 device after power cycle Reason for Advisory Notice Rad 8 device has been noted to revert back to factory default settings
33. issue may cause you and would like to thank you in advance for your patience and cooperation while we actively work to remedy the issue presented above Sincerely nv 2 RM ver ette n p 1 js A OS i ma Tony Roberts Vice President of Quality Assurance 40 Parker vine CA92618USA o 3 of 3 B BRAUN B BRAUN MEDICAL N V S A Woluwelaan 140 b B 1831 DIEGEM RA TVR cvg 24 01 2011 Diegem 24 januari 2011 Recall Redon Drainage TUBE 50CM CH 10 Als 100 Europees familiebedrijf streeft B Braun Medical N V er steeds naar om kwaliteitsproducten ter beschikking te stellen van het ziekenhuis en is de pati ntveiligheid en uw tevredenheid onze belangrijkste bekommernis In dit kader wensen wij u op de hoogte te brengen van een recall voor het product Redon Drainage TUBE 50CM CH 10 Vanuit ons moederbedrijf werd ons melding gemaakt van een onvolledige lasnaad bij een single unit verpakking van de Redon drain Dit kan invloed hebben op de steriliteit van het betreffende product We kunnen niet uitsluiten dat andere producten uit dit lot hetzelfde defect vertonen Daarom vragen wij u om dit lot niet meer te gebruiken Om mogelijke problemen te vermijden heeft B Braun Medical N V beslist om dit lotnummer terug te halen uit de markt Het betreft de terugroeping voor Artikelnummer Omschrijving Lotnummer 02111000 Redon Drainage TUBE 50CM CH 10 9K19340000 Om de recallprocedure vlot te laten ve
34. klanten die gebruik maken van de Baxter transfer sets is het aanbevolen om voor de verbindingen gebruik te maken van de Titanium adapter Baxter product code 5C4129 deze adapter bevat een compatibele geometrie die een veilige connectie met de Baxter transfer sets verzekert Gelieve u ervan te verzekeren dat onafhankelijke tests van Covidien bevestigd hebben dat de Quinton Beta cap adapter volledig aan alle interne en externe normen en specificaties voldoet Daarom wordt deze waarschuwing alleen gericht aan klanten die mogelijk deze Peritoneale dialyse toestellen samen met de Baxter overdracht sets gebruiken Gelieve deze brief te bezorgen aan alle collega s binnen uw organisatie die ook op de hoogte moeten zijn van deze kennisgeving en ook te bezorgen aan elke organisatie persoon waarheen deze toestellen gestuurd zijn Gelieve ook gedurende een toepasselijke periode bewust van deze kennisgeving te blijven Als u enige problemen ervaart met de Quinton Beta cap adapter gelieve dan contact op te nemen met Martine Hermes op telefoonnummer 015 29 81 41 Met vriendelijke groeten 25 TE Martine Hermes National Sales amp Marketing Manager Benelux Venous Solutions ATTACHMENT A_ Beta Cap Adapter09 12 ItemCode 8810887003 8810888003 8810888012 8810889003 8810889011 8810890003 8810890014 8811313009 8811313010 8811313013 8811313014 8811313015 8812321001 8812329001 8812329002 8814843001 8814843002 8815677001 8817278001 881727
35. ongemak Extra informatie Systeem Validatie Naast het gebruik als een standaard methode voor een periodieke controle van het sterilisatieproces in het STERRAD Sterilisatie systeem 1s de STERRAD CYCLESURE 24 Biological Indicators BI ook een onderdeel van de validatiekits die worden gebruikt tijdens de installatie van het STERRAD Sterilisatie systeem Uit onze administratie blijkt dat bij STERRAD Sterilisatie systemen die tussen februari 2008 en december 2011 zijn geinstalleerd en gevalideerd de betrokken lotnummers vermeld in bijlage 1 zijn gebruikt echter de tijdens het validatieproces gecontroleerde paramaters en het mechanisch functioneren van de sterilisator zijn niet afhankelijk van de STERRAD CYCLESURE 24 Biological Indicators BI Het risico op infectie voor een individuele pati nt 1s gering aangezien de biologische indicator slechts een van de middelen is waarmee een sterilisatieproces wordt gevolgd Indien u de STERRAD CYCLESURE 24 Biological Indicators BI gefabriceerd sinds januari 2012 en met een 6 maanden houdbaarheidstermijn heeft gebruik kunt u ervan verzekerd zijn dat het product controleert of aan de juiste sterilisatievoorwaarden is voldaan lotnummers gefabriceerd in 2012 zijn herkenbaar aan het cijfer 2 als vijfde cijfer van het lotnummer bijvoorbeeld 083127 Voor die landen waar het STERRAD Sterilisatie systeem jaarlijks wordt gevalideerd zal de volgende hervalidatie plaatsvinden als onderdeel van een
36. que la connexion est bien s curis e Pour les clients qui utilisent les dispositifs de transfert Baxter il est recommand que les connexions soient faites avec les adaptateurs en titane Baxter r f rence produit Baxter 5C4129 dont la conception g om trique permet une connexion s curis e avec les dispositifs de transfert Des tests conduits par une tierce soci t ind pendante de Covidien confirment que l adaptateur pour cath ter de dialyse p riton ale Beta Cap est conforme aux sp cifications et aux mesures tant internes qu externes En cons quence cette information relative la s curit ne s adresse qu aux quipes m dicales qui pourraient utiliser l adaptateur Beta Cap conjointement avec le dispositif de transfert Baxter Nous vous remercions de bien vouloir diffuser cette lettre d information l ensemble des personnes concern es par cette alerte au sein de votre organisation dans les services se trouvent ces deux dispositifs Cette information doit rester accessible aux personnes qui pourraient tre concern es pendant une p riode appropri e sa compl te diffusion N h sitez pas contacter Martine Hermes num ro de t l phone 015 29 81 41 si vous rencontrez des probl mes d utilisation avec l adaptateur Beta Cap Nous vous prions de recevoir Madame Monsieur l expression de nos sinc res salutations Martine Hermes National Sales amp Marketing Manager Benelux Venous Solutions ATTACHMENT A B
37. regulier gepland onderhoud binnen 12 maanden Voor die landen waar het STERRAD Sterilisatie systeem niet jaarlijks wordt gevalideerd dient u contact op te nemen met uw locale ASP Technische Service Hoogachtend Johnson amp Johnson Medical N V F M J Reijntjens Quality Manager Benelux N VERATHON MEDICAL DRINGEND Sicherheitsmeldung GlideScope Videolaryngoskope 19 November 2012 30 Oktober 2012 R ckruf R ckholung medizinischer Ger te Sehr geehrte GlideScope Kunden und Kundinnen Verathon Medical Hersteller von GlideScope Videolaryngoskopen f hrt einen freiwilligen R ckruf von spezifischen wiederverwendbaren Videolaryngoskopspateln durch bei denen es m glicherweise zu Br chen kommen kann Diese Videolaryngoskopspatel sind kompatibel mit dem analogen GVL GlideScope Monitor und wurden im Zeitraum Dezember 2010 und August 2011 hergestellt Die betreffenden Ger te dieses R ckrufs sind GlideScope GVL Spatel Gr e 3 Artnr Seriennummer 0574 0007 MD105000 bis MD112387 GlideScope GVL Spatel Gr fse 4 Artnr Seriennummer 0574 0001 LG105000 bis LG112758 GlideScope GVL Spatel Gr e 5 Artnr Seriennummer 0574 0030 XL105000 bis XL111798 Die Gefahr bei den betreffenden Spateln besteht in m glichen Spannungsrissen an der Spitze der Spatel die bei einer Routineinspektion vor der Anwendung nicht direkt erkennbar sind Diese Risse k nnen irgendwann zum Bruch des Ger tes f hren Bis heute wurden
38. reur autre pr ciser QUESTIONNAIRE COMPLETE PAR Nom Fonction T l phone Soci t Adresse Ville Pays Merci de retourner ce document renseign par fax au FAX 937 526 7448 RE M11 Sterilizer FCA ou par mail a l adresse suivante fieldcorrection midmark com URGENT CORRIGERENDE PRAKTIJK MEDISCH APPARAAT Vereist voor oudere modelnummers van de Midmark M11 Ultra Steam Sterilizer Getroffen M11 Steam Sterilizer Modelnummers M11 001 M11D 001 M11 001R M11 002 M11D 002 M11 002R M11 003 M11 004 M11 005 en M11 006 23 mei 2012 QARA Compliance Afdeling Beste Distributie Partner Om voor het voortdurend effectief gebruik van onze producten te zorgen neemt Midmark contact met u op om u van extra labels te voorzien in de vorm van een waarschuwingssticker voor de bovengenoemde oudere modellen eenheden die tussen 1994 t m 2003 geproduceerd zijn met rode LED displays en met de vermelde serienummers en voorvoegsels van onze M11 Steam Sterilizers Midmark doet dit nadat zij rapporten heeft ontvangen dat een zeer klein percentage eindgebruikers de deur niet correct sloten alvorens de eenheid in werking te stellen De volgende illustraties geven de locatie weer van de rode display en waar het serienummer en modelnummer zich op de eenheid bevinden ACHTERKANT van de sterilisator N B Het serienummer van de eenheid bevinat zich ook aan de binnenkant van de deur indien het moeilijk is om toegan
39. the operation of the LED battery insert with HEINE rechargeable batteries You can use the device safely until it is replaced Transmission of this Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred Please transfer this notice to other organizations on which this action has an impact Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action The undersigned confirms that the relevant Competent Authorities have been informed of this Field Safety Corrective Action Contact reference person As an end user please contact your authorized dealer or distributor to arrange for replacement If you are an authorized dealer or distributor please contact your representative in Customer Service during regular business hours for the processing of your replacements You will find more information concerning this procedure on the following page Should you still have questions please contact Carola Janisch Manager Customer Service Phone 49 8152 38 0 Fax 49 8152 38 202 email info heine com We would like to emphasize here that we very much regret this situation and apologize for all the effort and inconvenience involved At the same time we want to express our sincere thanks for your help and support oincerely HEINE Optot
40. tout renseignement compl mentaire et vous prions d agr er Madame Monsieur l assurance de notre sinc re consid ration NB dans le cadre de notre suivi Qualit merci de bien vouloir nous retourner le formulaire ci joint au verso Cordialement ad LL a rum ir Koen Waelput Serge Hopchet Quality Manager Division Manager Medical Systems OLYMPUS BELGIUM N V Boomsesteenweg 77 B 2630 Aartselaar Tel 32 0 3 870 98 O Fax 32 0 3 887 24 26 www olympus be Deutsche Bank Brussels 826 0004292 41 IBAN BE88 8260 0042 8241 BIC DEUTBEBE RPR RPM Antwerpen B T W T V A BE0405 804 052 e T VRheinland quy TN 4 o A 97105043 OLYMPUS Your Vision Our Future Accus de r ception du Correspondant de Mat riovigilance Ref QIL 145 006 Objet Conseil de S curit Rappel sur le nettoyage et la d sinfection du duod noscope TJF Q180V Merci de renvoyer ce formulaire OLYMPUS BELGIUM NV ir Waelput Boomsesteenweg 77 B 2630 Aartselaar FAX au 32 3 887 24 26 e mail quality olympus be Nom Fonction Service Nom tampon de l tablissement Rue Ville Nom du Correspondant de Mat riovigilance T l e mail Date Signature Nous accusons r ception de l information laquelle a bien t transmise aux services concern s OLYMPUS BELGIUM N V Boomsesteenweg 77 B 2630 Aartselaar Tel 32 0 3 870 98 O Fax 32 0 3 8
41. visible in the endoscopic or sonographic field of view leading to the possibility of patient injury such as a perforation The aspiration needle is derailed from the elevator Figure 1 1 2 HOYA CORPORATION DE NTAX PENTAX Life Care Division Medical Instrument SBU Quality Assurance Department Field Corrective Action IFU Addendum for proper use of endoscopic accessories with PENTAX EG 3870UTK Ultrasound Video Gastroscope Instructions The instructions specific to the use of the EG 3870UTK Ultrasound Video Gastroscope in combination with endoscope accessories have been updated to include additional figures cautions and warnings see attached addendum to the Owner s Manual PENTAX Ultrasound Upper Gl Video Scopes Part number Z485 to aid in the proper method for advancing the endoscopic accessory into the field of view Therefore we would like to ask all the users to read and carefully follow the attached addendum in order to properly operate the EG 3870UTK Ultrasound Video Gastroscope in combination with endoscope accessories Please ensure to update the appropriate sections of the Owner s Manual PENTAX Ultrasound Upper Gl Video Scopes Part Number Z845 Revisions ROO through R12 with the attached addendum Failure to follow the addendum may result in possible injury to patient The Owner s Manual PENTAX Ultrasound Upper Gl Video Scopes Part Number Z845 is being revised concurrently to incorporate the updated set of inst
42. vous faciliter la t che Informations suppl mentaires Validation des syst mes En plus de leur utilisation comme m thode standard pour le contr le fr quent des cycles des syst mes STERRADS les indicateurs biologiques STERRAD CYCLESURE 24 sont galement un l ment des kits de validation utilis s durant l installation des syst mes STERRAD Selon nos registres des syst mes STERRAD install s et valid s entre f vrier 2008 et d cembre 2011 ont t install s en utilisant un produit IB concern On notera que le processus de validation a v rifi des param tres et des op rations m caniques du st rilisateur qui ne sont pas d pendants du produit IB STERRAD CYCLESURE 24 concern Le risque d infection pour un patient individuel est minime tant donn que l indicateur biologique n est qu un de trois dispositifs de contr le des syst mes de st rilisation Si vous avez utilis un indicateur biologique STERRAD CYCLESURE 24 fabriqu depuis janvier 2012 dans les limites de la dur e de conservation de six mois vous pouvez tre certain que le produit v rifie que des conditions de st rilisation ad quates sont atteintes les lots fabriqu s en 2012 peuvent tre identifi s par le num ro de lot qui contient le chiffre 2 comme cinqui me caract re par exemple 083127 Dans le cas des pays o le syst me STERRAD est revalid une fois par an la prochaine revalidation aura lieu dans le cadre d un programme d
43. 0 1 ZO6DPLL SITOPLI eus aqn g3 uouag i 9us 8220080010 00L9 LLX 2914611 LASSBLL Brid2kl EOLZOLL HIGLYLI Wdip SHuouog LrvH9LS 48U5 eqn 13 BPELOEL GILOOEL LECO6LL Oy269LL GELGYLL 811 91 065291 HOE u0SSeo0y Rind CO060V LO 5860080410 610080412 8620080310 22 00800 Lo 86200 0ML0 0900040L0 GEBELEL ZZBOLZL LATLYTL LEGGLEL PSSCELL EEEOGLL OSPESLL 2666210 60054 BPLELI CZSEOLL POLZOLL ZLOSSLL COSZHLL Z90LHLL BOGIELL 4910090710 78 0080Mi0 ZLOO80MLO 2910080910 9GE00804L0 2600080410 0070080310 ZE 00803 LO 7900080310 9770020110 OS 00201 LO 48700409110 9 06PX 1996811 X SETPSLLX LEUSGLLX 2826201 LYEBLTL ELBOLEL 288 vvZI OLOLVEL DOGLVEL SZ9861 1 CSCZELL 666061 YALE SY uouolg 9594811 EDEZBLI CYGHGLL SZ9ESL L 9EGTGLL QEZLSL L O9PSFEL ZO0L7L S9EPPLL SEOZPLL SOGOPLL S6YLELL Hays egni 13 9176 9FL0080HL0 08Z0080HLO L GSOZL LZ8Z0Z1 2996L 58516 65698 ESLPBLL ZELPSLL PBGGLLL BLSELEL LOEELLL OBELZEL 2890211 HAGE 97 youo g vYLOOSOVLO 700 010 LOLDOLOMLO PEL LEZL 9826221 88LVLZ1 YSLOGZL LOGZVEL 9E9861 1 SKLEGLL EZZOGLL HAGE SH YoUdIg 1869811 4849211 9 69 EEOLSLL beLTSLI VETISLI 9098744 6PZOPLL LYGSHLL SEOLHLL ZOSSELL 498Y5 aqni 13 8900060010 Y387 SH YIUOIG 112113 804911 Es EGELGLL DZEISLI PEETGLL VEDETLL 4J9c0vl Y9v6ely BILL 447113 DGEELE Kan Sant 13 SES mod
44. 00 531 3309 Because we care a j pea Emp aa yim FR m 2 rr s Tim Taylor Director Quality Midmark Corporation Inclus Instructions de pose Sticker d avertissement Warning label Technical Service Bulletin Product Service Life Formulaire de retour Instructions de pose 1 S assurer que la surface destin e a recevoir le sticker est propre et seche 2 Retirer la protection au dos du sticker et positionner celui ci comme indiqu e ci dessous 3 Appuyer fermement sur le sticker pour s assurer de sa bonne tenue sur l appareil ACTION CORRECTIVE FORMULAIRE A RETOURNER R f rences concern es M11 001 M11D 001 M11 001R M11 002 M11D 002 M11 002R M11 003 M11 004 M11 005 and M11 006 Merci de cocher TOUTES les cases appropri es J ai bien pris connaissance des instructions mentionn es dans le courrier associ e l ACTION CORRECTIVE DE SECURITE datant du 09 janvier 2012 J ai appos le sticker d avertissement sur le s st rilisateur s portant le s N de s rie suivant s Mentionner le statut de l quipement concern par cette action Renseigner le s N de s rie l unit n est plus en service sp cifier la date de retrait l unit a t c d e merci de pr ciser quelle date ainsi que les coordonn es de l acqu reur l unit a t vendue merci de pr ciser quelle date ainsi que les coordonn es de l acqu
45. 01494 532761 Fax 01494 524630 ge in ae E mail orders uk teleflexmedicai com This recall is voluntary and all affected competent authorities have been advised of this Field Safety Corrective Action Teleflex Medical is committed to providing high quality safe and effective products We sincerely apologize for any inconvenience this action may cause your operations If you have any other questions fee free to contact your local sales representative or Customer Service at 91494 532761 Mairsil Claffey VP Quality Assurance amp Regulatory Affairs EMEA Attachments Appendix A List of batches affected by this Field Safety Corrective Action Appendix B Recall Acknowledgement Form amp Stock Status Form A M pne en Sh mm rm rr mr 960060010 SELOOGOVLO 00060V LO ZLE0080N LO 42008014L0 90Z0080W LO PZS00801 0 6750080710 9900080110 1900080110 Zr LOO8OMEO 8 00080M LO LL00080910 ZZ0080F LO 2200807 LO 6rLOOBOFP LO 00080 10 0P0090HLO 6L 00805L0 SSE0080410 0620080410 82 0080310 ZEZOOSGALO 90008031L0 SLZ0080QX1LO 98100800L0 9010080010 956008080 6610080910 L2000808L0 LOCOOZOWLO 00 00401L0 S2200401L0 9600020740 SS000201L0 S8L8 EZLX FESL8ELX PEQOSLLX 068641 LX EELLBEL 60 0941 EVZOBZL vvL442 D6BELZL LGRELZL GLBOLEL Z8L99Z LOGVOEL SOLEITL GLIGSTL LITTSTIL Cav Gc EGGSPZL GLZOPZL Pr96EZL GELBETL OGZLEZI SOEYEZL LOLZEZL BGELEZL
46. 2 031 14 00 5952 031 17 00 5952 031 20 90 5952 031 17 90 5952 031 20 00 5970 031 09 00 5970 031 10 00 5970 031 12 00 5970 031 14 00 5970 031 17 00 5970 031 20 90 5970 031 09 90 5970 031 10 90 5970 031 12 90 5970 031 14 90 5970 031 17 90 5970 031 20 Micro Articular Surfaces Striped Yellow Femur A B Tibia 3 4 NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 9mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 14mm Height NexGen Cruciate R
47. 4 7559375 10281150 10281151 10281152 en 10281153 Onze service ingenieur zal uw MAVIG PORTEGRA 2 systeem tijdens de volgende onderhoudsbeurt controleren en het stuk toevoegen indien nodig Boven beschreven probleem houdt geen risico in voor pati nten die eerder met behulp van dit systeem behandeld werden Schade te wijten aan dit probleem is onwaarschijnlijk Toch kunnen wij een impact op de werking van het systeem of het loskomen vallen van stukken niet uitsluiten in het bijzonder bij een beschadiging bv ten gevolge van een collisie Wij wensen er u bij deze gelegenheid aan te herinneren dat u onafhankelijk van dit probleem steeds bij ons terecht kunt in het geval van enige beschadiging of onregelmatigheid van het systeem zie hiervoor ook het desbetreffende hoofdstuk in de bedieningshandleiding Wij verzoeken vriendelijk om de gebruikers van het MAVIG PORTEGRA 2 systeem hierover in te lichten evenals alle andere betrokken personen Siemens Group Belgium Luxembourg Tel 32 0 2 536 21 11 Healthcare Sector Management Luc Van Overstraeten Fax 32 0 2 536 24 92 Customer Service Division Management Stefaan De Moor www siemens be Maatschappelijke zetel Siemens nv Marie Curiesquare 30 1070 Brussel Belgi BTW TVA BE 0404 284 716 RPR Brussel RPM Bruxelles BNP Paribas Fortis 210 0040988 09 Deutsche Bank 826 0004664 25 Erkenningsnummers Num ros d agr ment Beveiligingsonderneming Entreprise de s curit 20 1321 06 E
48. 8006 8817278007 8817278008 8888285001 8888410506 8888410514 co Co 00 OG I b HP O O o co oa 100 Co Co 00 60 Co co 00 oo 00 o oo 00 OO Die IR IH pa ps pa hs pa ha gt o 145 145 A 11M io iuo ajo 09 loo o CO oo CO Co CO co oo 60 CO Co oo co CO Dail pa lb pa im PININ lla Re 1019 gt 111810 ww In iS lo ID co oo oo Co oo Go i co 69 00 co oo Co co ain A ala w w IN ln w ui to Product Description STRT TENCKHOFF LOOSE CUFFS 42CM X1 SIRT TENCKHOFF 2 CUFFS 42CM X1 TENCKHOFF STRT CATH UNIV 47CM X1 SUBCUT PSTION STRT 42CM X1 SUBCUT 46CM STRT TENCKHOFF X1 STRT PD TENCKHOFF 2 CUFFS 37CM X1 STRT PD TENCKHOFF 2 CUFFS 32CM X1 CRL CTH W LOOSE CUFFS 62CM X1 PERIT CURL 62CM TWO CUFFS X1 CURL CATH 1 CUFF 60CiVI X1 CURE CATH 1 CUFF 56 5CM X1 PERIT CURL 57CM TWO CUFFS X1 SUBCUT STRT PED TENCKHOFF 37CM X1 TENCKHOFF SUBCUT STRT NEONAT 31CMX1 STRT NEO TENCKHOFF 2 CUFFS 31CM X1 STRT TENCKHOFF 1 CUFF 41CM X1 STRT TENCKHOFF 1 CUFF 46CM X1 PED CURL CATH 39 25 1 CUFF X1 ACUTE PERIT DIALYSIS KIT X5 CURL CATH PERIT KIT 62CM X5 CURL CATH PERIT KIT 57CM X5 STRT TENCKHOFF PERIT KIT 42CM X5 PERI PATCH REPAIR KIT 71 X1 SN TENCKHOFF L PED SP2 LT X1 SN TENCKHOFF R PED SP2 RT X1 OREOP ZELLERMAN OZ TWH99 DBC2 X1 TENCKHOFF T202 X1 TENCKHOFF T201 Q X1
49. 87 24 26 www olympus be Deutsche Bank Brussels 826 0004292 41 IBAN BE88 8260 0042 8241 BIC DEUTBEBE RPR RPM Antwerpen B T W T V A BE0405 804 052 OLYMPUS Your Vision Our Future Aartselaar 15 Januari 2013 INFORMA TIEBRIEF Veiligheidsadvies QIL 145 006 Reiniging en Desinfectie van de Duodenoscoop TJF Q180V Geachte Olympus klant Ten gevolge van een recentelijk gerapporteerd geval van een verontreinigde Olympus Video Duodenoscoop TJF Q180V willen we uw aandacht vestigen op volgende punten Volg strikt alle instructies zoals aangegeven in de reinigingshandleiding voor de TJF Q180V Besteed speciale aandacht aan de gedetailleerde voorafgaandelijke reinigingsinstructies vooral voor de distaal uiteinde en de hevel van de scoop Bijgevoegd vindt u een beknopte handleiding als hulp Deze dient beschouwd te worden als bijkomende informatie voor de reinigingsinstructies uit de handleiding Ter aanvulling van de bovenvermelde punten willen wij u eraan herinneren dat de TJF Q180V net zoals alle Olympus endoscopen een grondige voorbereiding en inspectie dient te ondergaan vooraleer gebruik bij pati nten In geval u enige schade of onregelmatigheid vaststelt mag de endoscoop niet meer gebruikt worden en dient u Olympus te contacteren voor inspectie en herstelling Het gebruik van een slecht werkende endoscoop kan pati nt of gebruiker verwonden en kan leiden tot ernstigere beschadiging van het materiaal V
50. 9340000 Redon Drainage TUBE SOCM CH 10 Gelieve ons de aantallen van de betrokken referentie mee te delen via bijgevoegd antwoordformulier Van zodra wij uw formulier hebben ontvangen wordt u verwittigd wanneer we de goederen komen ophalen De ingeleverde gocderen worden vervangen door een nietiw lot 32 0 70 22 33 OO info bedpbbraun com RPR Brussel RPM Bruxelles 32 0 70 22 33 88 order be G bbraun cern BTW TVA BE O407 089 994 Smith amp Nephew Orthopaedics AG T 41 0 62 832 06 06 adi Schachenallee 29 F 41 0 62 832 06 07 ar smith amp nephew 5001 Aarau www smith nephew com Switzerland Recipients Address January 31 2012 URGENT FIELD SAFETY NOTICE Medical Device Field Safety Corrective Action Reference R1109 Concerned Devices SpatialFrame com Software Version 4 1 1 SpatialFrame com Software 71070401 Dear Dr This letter is to inform you of a field action regarding a specific version of the SpatialFrame com Software This field action has been reported to the relevant competent authorities Produ SpatialFrame com Software Version 4 1 1 Reason for this It was determined that under certain rare conditions the software could produce a strut Field Action adjustment schedule with a duration longer than anticipated Strut adjustment schedules which were printed after selecting Save As selecting the Prescription tab and selecting Printable PDF Version between March 19 2011 and August
51. 9K19340000 ME EEE AMM A E RIEN NITRATE DTP bevestigt in het kader van de recall van Redon Drainage TUBE 50CM CH 10 U2111000 J deze producten in voorraad te hebben en ter beschikking te stellen van de firma B Braun Medical N V S A Het aantal ingevuld op de onderstaande tabel mag worden opgehaald op volgend adres RADA SSSR SSS dad nen AAA AAA AAA rd nende NNN NNN TER BEE Eee een FSSC STS SSS NENNE NTN NNN ENE NENNE NENNE AEE arenaen DIS SS ISSN ESS SS SZ ES enken EIS SETTER TREO DURAND DO OR DR OR EHER RO rr Arda AAA IIA IAEA AAA Aaa O het betreffende lotnummer niet in voorraad te hebben Datum Handtekening stempel Dringend terug te faxen t a v Patricia Coeckelbergh op 070 22 33 88 Graag antwoord voor 31 januari 2011 Artikelnummer Hoeveelheid in stock umoo asooo O O O o o oo S 0 Resul taat TX rapport P 1 24 01 2011 14 16 Serial No A02EW21005376 TC 190216 Bestemming Starttijd Afdr gest 0053724589 01 24 14 15 00 01 07 003 003 pn Li Lin L2 Lian TMR Timer TX POL Afuragen ORG Anares Ang Origineel Ear Maas Frame wissen TX MIX Gemengd origineel TX CALL Handmat ge x CSRC CSRC FWD Doorsturen PC PC Fax BND Dubbelzijdige bindrichting SP Speciaal origineel FCODE F code RTX Re TX RLY Relay MBX Vertrouwelijk UL Bulletin SIP SIP Fax IPADR IP adres fax I Fax Internet Fax OK Com
52. ANDE Etablissement N T l 02 536 46 10 Fax 02 536 46 74 Fonction GSM Rue E mail Secr tariat marion wesendonkOsiemens com Ville Votre r f rence Notre r f rence H IM RR mw P1124 Date le 10 ao t 2012 Information de s curit concernant syngo Imaging XS calcul incorrect des valeurs d chelle de gris pour les images d une profondeur de pixel sup rieure 12 bits Formule Par la pr sente nous d sirons vous informer d un dysfonctionnement potentiel lors de l utilisation de syngo Imaging XS version VA70A ou sup rieure Dans certaines circonstances les valeurs d chelle de gris dans les fonctions Region of Interest Pixel Lens Edge Enhancement et Histograms ne sont pas calcul es correctement Dans quelles circonstances ce dysfonctionnement survient il La valeur minimale maximale de la densit pixel dans les fonctions Region of Interest Pixel Lens Edge Enhancement et Histograms n est pas calcul e correctement pour les images d une profondeur de pixel sup rieure 12 bits Veuillez noter que les mesures en question affich es dans les images r alis es ant rieurement ne sont pas correctes non plus Par contre toutes les valeurs calcul es pour les images d une profondeur de pixel inf rieure ou gale 12 bits sont correctes Que peut faire l utilisateur pour viter ce dysfonctionnement Veuillez v rifier au sein de votre tabli
53. ATH C CA1 X1 SWANNECK SN T2 LT X1 SWANNECK SN T2 RT X1 SWANNECK SN T2 LONG LT X1 SWANNECK MISS SN M2 LT X1 SWANNECK MISS SN M2 RT X1 SNROZTW H2 LT X1 SN LSN OZ TW H2 RT X1 Page 1 ATTACHMENT A_ Beta Cap Adapter09 12 8888413100 Peritoneal Dialysis Catheter INFANT SWAN NECK CURL CATH 38 9CMX1 Page 2 Synthes GmbH Luzernstrasse 21 Tel 41 61 965 61 11 4528 Zuchwi Fax 41 61 965 66 01 SYNTHES Switzerland www synthes com To the ATTENTION of Doctors using Synthes Mandible Distractor multiaxial 01 October 2012 URGENT MEDICAL DEVICE PRODUCT REMOVAL Part Description Part Number Part Number Part Description Lot Number 487 931 Distractor Body Titanium Alloy TAV 7895264 7793390 7583381 7583380 7528840 3708643 3683421 3683403 3560888 487 966 Mandible Distractor multiaxial right 7765627 Titanium Alloy TAV 7562081 7532790 3800757 3757207 487 967 Mandible Distractor multiaxial left 7834374 Titanium Alloy TAV 7662788 7562083 3757213 3739743 Instruments and implants Instrumente und Implantate Instruments et implants Instrumentos e implantes Strumenti ed impianti approved by the AO gepr ft und freigegeben von approuv s par l AO aprobados por la AO approvati dalla Foundation der AO Foundation Foundation Foundation AO Foundation SYNTHES Page 2 of 3 Dear Doctor Synthes is initiating a Medical Device Product Removal related to the Synth
54. CLPOET EBG6ZZL LOBHZZL EZIBLZL BIEELEL OPOLOZL YILOOZL ESEGELL OPLEBLL EZOCELE Gr606L CEOGBLL 6618811 LZEDBLL GPPESLL S866LLL 5909211 SOZSZLL IGSOLLL OLLZOLL PSSSOLL ZELGSLL PZBBGLE LZYESLL SE9ZSLL EHPOSLL DEYEFLL 668 91 CVESVLL EBESHLL 620SPLL LSLEPLEL PESEVLL DEYLFLL QOTOPLL 996 PEIELL DOBOELL S96S LL OZOPELL OSEVELL 1000060010 S E0060910 8000600910 6220050810 6800080NELO BSODOBONLO 6200807L0 ZEZ00801L0 9 Z0080AL0 GLZOO080MLO BSVOO8OFLO ESPOOBOFLO LZL0080HLEO 9500080HLO 8820080410 1610080310 9690080110 1640080410 9900080GL0 6810080210 0220080810 ZOLOOBOVLO 6620020710 1700 07110 BZZBSLIX TSEBVL IX ErZOSZL S8Z6LZ 1 682v4Cl 54 1 4404 96o99zL EIBEIZL 80692 HOLEIEL 306191 DEGBSEL VOSTSTL PSZYYZL SPREVTL SOSLPZL LACLbal TLPBETL ONBSETL LLOOLZL GOSLLZL SLLOLZL OLEGOEL vEOLOCI LZ21S61L GIEPBLL So69LL 8965811 ZPPESLL ESPELLE ZvvVALE PSSOLLL HIGSILL OZPSOLL ZZLPOLL HOGLGLI OTOGGLL LE96PL I 9968g I EBLOPLL VBESVLL LOLSYLL SALEPLL OLDEDLL LOSERLI LZOZPLI 69ZO LL SISBELL 6910080110 6820080110 610080310 ZOSZSZL 965 LGELELL GOZELZL Z1990Z ETBEOIL 800060010 29 0050V10 SLOCOSOFLO 6 10080 10 2920086910 r820080410 0L00808L0 S 986L LX aoeae LX 1999221 8115611 OSLEGLL 7929811 Z6Z08LI LISELLL 1007411 0808911 Fr969
55. LL 920v9LL 868091 99915 LL 9869511 OOPOSLE LEOSSLL 9Z9ESLL BIGEGLE 0696611 9 00060v LO OSZOOSONLO S000080710 Y5 00903L0 Cez0090410 LyE00803L0 v010080010 SHZDOBOVLO v 20020110 9 069c1 BEEBSZL FPEZLZL OZOLOZL GRPPELL 6699LL 00288LL 66 84L1 TZSELLL GYOGOEL ELLOELL HIKGELL TIETEN SISQUINN 307 PODSHY SHASNNN HOLVA S302 19ndOMNd 0319344 HONOHE FH3HS PUL AIMS FHAHS 0 SOLON ALddvS INSOun v HALE ST YDUOIG 1945 eqni 13 2 091 G HIGE ST YIUOIG p1eus egni 13 4182 ST Youolg ays OUNL 13 82091 5 O 3 AMS H9us AIMS 794S LOES L uonduoseg jonpoag iri roO jon Pad TYDIGIN xd jo Snid BAON LYZ0060W10 vbtO030DLO 7S 0080010 2020080810 6000808910 612143 269897 584991 1009921 SHOPECZL HABE S7 NM 6 09L SA VELSLZL GLLPLTL PZOS6LL GOLZELL 9866 EL NBL 90921 1 SSSOZLL O8OVOLL BIOLGLL 686261 IGZEELL 1 494U5 sant 93 Sn d BAON 90Z0060YLO SZ00080P LD StYO0809LO 1810080210 1020080910 BSEO0LOMLO 90 0881 LEEBLEL BLLLLTL 159921 HAZE ST uouoig un 90 9 2 vS 66 LL V 0 6LL 05660611 BIGSBLL ZUEZELL 9909ZLL PZBEOLL 62909 OOGSGLL TIYEGLL SBESPLL 9ug eqni 93 ZE09L SA Snid EAON S O9L GA ZOVOOBOHLO 12900080H LO MAGE ST u2uoJg 8970080010 2810080WLO TIEGIZL OPSPHZL 2628061 SEBLOZI 9 V6LL BYHESLL vOr94LL 008
56. Nr DE 87119271 Interne ID 15 2012 02 15 EN FSN HEINE Catalogue Number Catalogue Number Article Description Article Description LARYN LADEGR STAND F O LLED F 008 22 891 FLEXTIP LED LARY SET FT3 FT4 F 230 18 860 F O LED LARYN SET F 119 F 119 18 860 FLEXTIP LED LARY SET FT3 FT4 F 230 28 865 GR FO LED LARYNG SET F 120 F 120 18 860 DEMO SET UPGRADE LARYNGOSCOPES F 261 20 820 F O LED LARYN SET F 119 F 119 28 865 FLEXTIP LED LARY SET FT3 FT4 F 230 28 865 Description of the problem We received a few isolated reports from users about illumination failures of the above mentioned LED battery inserts for the HEINE FO Standard Laryngoscope A failure to illuminate could lead to a delay in intubation or the inability for intubation to be performed if alternative devices or an alternative means of airway management is not available or not available in time In some rare cases the affected battery inserts can have contact problems when operated with primary cells batteries of certain manufacturers The cause of the failures has been identified as a contact between the LED battery insert and the positive pole of the batteries that is susceptible to interruption This was observed if the batteries were strongly compressed e g after a fall or when the positive pole of the battery did not fit mechanically to the contact of the LED battery insert Up until now we have recognized this problem in performance when using batter
57. ORI nummer Num ro EORI BE04 SI E M N Brief Ref HIM GR mw R16456 van 15 oktober 2012 Indien dit systeem hebt verkocht en het niet langer in uw bezit is vragen wij u vriendelijk om deze veiligheidsinformatie door te sturen naar de nieuwe eigenaar Gelieve ons in dit geval ook mee te delen wie de nieuwe eigenaar van dit systeem is Wij danken u voor uw begrip en medewerking Hoogachtend Siemens naamloze vennootschap Rik De Winter Stefaan De Moor Service Modality Manager Service Director Mechelen 5 Oktober 2012 Belangrijke Veiligheidskennisgeving Peritoneale dialyse toestellen met de Quinton Beta cap Adapter Geachte klant Deze waarschuwing wordt uitgestuurd om Covidien klanten te verwittigen van een reductie in de verbinding tussen de Quinton Beta cap adapter code 8814661001 en de Baxter transfer sets codes 5C4325 504482 5C4483 R5C4484 en 504449 De reductie in de verbinding kan leiden tot een verhoogd risico van separatie wat mogelijkerwijze kan resulteren in peritonitis Wij hebben vernomen dat Baxter aanbeveelt om deze twee producten niet meer samen te gebruiken Als een van de Peritoneale dialyse toestellen vermeld in bijlage A van deze brief deze bevatten allemaal de Quinton Beta Cap Adapter toch gebruikt wordt met de Baxter transfer sets raden wij aan dat de arts extra voorzichtig is om te verzekeren dat de verbinding tussen de Quinton Beta Cap Adapter en de Baxter transfer set goed vast zit Voor
58. RELANCES MERCI DE VOUS ASSURER QUE LES DONNEES CI DESSOUS SONT COMPLETEES BAXTER NE PEUT PAS TRAITER DES FORMULAIRES NON SIGNES VOTRE REPONSE A CETTE DEMANDE EVITERA LES RELANCES INUTILES CONCERNANT CE PROBLEME Je confirme avoir recu le courrier susmentionn avoir ex cut les actions soulign es dans le courrier et diffus ces informations de la mani re appropri e nos quipes nos patients trait s domicile et tout autre service qui s av rerait n cessaire Nous avons r pertori le nombre suivant de Guide Patient Domicile 07 19 64 016FRE pour les Systemes de DPA HOMECHOICE et HOMECHOICE PRO Merci de lister le nombre de Guides Patient affect s afin que le nombre exact de Guides Patient corrig s vous soit envoy Nom et adresse du centre Confirmation de r ponse compl t e par Fonction Num ro de t l phone Signature Date CHAMP OBLIGATOIRE FCA 2012 003 RN HomeChoice error in French manual URGENT FICHE D AVERTISSEMENT ACTION CORRECTIVE DE SECURITE Recommand e pour les st rilisateurs Midmark M11 fabriqu s entre 1994 et 2003 R f rences des modeles concern s M11 001 M11D 001 M11 001R M11 002 M11D 002 M11 002R M11 003 M11 004 M11 005 and M11 006 Date Cher Partenaire Afin de garantir l utilisation de nos produits en toute s curit nous vous informons ce jour de la n cessit d apposer un sticker additionnel d avertissement sur les modeles
59. Verathon Medical keine Personensch den durch dieses Problem gemeldet berarbeitete neue Design und Herstellungsprozesse seit August 2011 haben dieses Problem gel st Wir haben das Design des Videolaryngoskopspatels berarbeitet und es dem gr ten anzunehmenden Unfall ausgesetzt sodass bei Druck zwischen zwei Verbindungselementen des Spatels mitunter bei hoher inneren Spannung diese Risse erzeugt wurden Um den Ausfall Ihres GlideScope Systems zu minimieren ersetzt Verathon Medical Ihnen kostenfrei den defekten betreffenden Videolaryngoskopspatel Ihr kostenfreier Austauschspatel wird eine volle Jahresgarantie haben Wenn sie weitere Fragen zu diesem R ckruf haben wenden Sie sich bitte an Verathon Medical unter 02664 911284 oder an Ihren zust ndigen Aussendienstmitarbeiter Verathon Medical Deutschland Siegener StraBe 32 D 56477 Rennerod Tel 49 0 2664 911 284 Fax 449 0 2664 911 285 CE E mail Infode verathon de Internet www verathon eu Inventors of BladderScan VMode and ScanPoint 0413 N 2 A VERATHON MEDICAL Die zust ndige Aufsichtsbeh rde hat Kenntnisnahme von dieser R ckrufaktion Bitte berichten Sie jeden auff lligen Defekt oder Verdacht auf Fehlfunktion an den Kundenservice von Verathon Medical oder an die zust ndige Aufsichtsbeh rde Vielen Dank f r Ihre erh hte Aufmerksamkeit Verathon Medical verpflichtet sich zur h chsten Produktqualit t und wir bedauern jegliche Unannehmlichkeiten die durch die
60. address the errors We will begin deployment of the patch in August 2012 Our records indicate that your facility has a Volcano s5 s5i Imaging System that is running either version 3 2 1 or 3 2 2 of Volcano s software Your system s will be updated by a Volcano representative at no cost to you In the interim the enclosed White Paper explains in detail the nature of the errors and how to avoid them Please ensure that the enclosed White Paper is circulated to the appropriate users and administrators in your facility Contact your Volcano sales representative if you have any questions or call our technical support group at the contact information below We are notifying the appropriate Regulatory Authorities of this voluntary field corrective action We regret the inconvenience On behalf of Volcano we appreciate your partnership and your continued support Sincerely Geert Verdonck Director Operations Contact information Please contact your local Volcano Corporation sales representative or Volcano Technical Service DI Excelsiorlaan 41 B 1930 Zaventem Belgium Y 32 27 13 18 21 B DL FieldServiceE avol Volcano Corporation Page 1of1 VOLCANO August 2012 TWO POTENTIAL SOFTWARE ERRORS AFFECTING DIGITAL AND ROTATIONAL IVUS CATHETERS INTERIM AVOIDANCE PENDING SOFTWARE PATCH This document discusses the software display errors that can occur in Volcano s5 s5i Imaging System when running either version 3 2 1 or 3 2 2 of V
61. ade will require sending the Rad 8 device back to Masimo Contact Information 1 of 3 INN Contact Masimo to obtain a Returned Authorization number or answer any questions or concerns you may have regarding the information above Region specific contact information is listed below AT fior E Me de i JA Y PA HE AMET 1 P mE uan p ave RARE in ae OE A De AE Eee TES IO LN e A ERST ui CES ri ELA mv fe Fh N fasi TAR ir Address amp Phone Number o er rry IC Eam ru ry dio neos CUT Masimo Europe Ltd Niederlassung Deutschiand Tel 49 89 800 65 899 0 Masimo International S rl Tel 41 32 720 11 55 Tech Services techservicesu masimo com ital Masimo Italy y Tel 39 02 450 76 308 Masimo Japan Tel 81 3 3868 5201 Masimo Latin America Email info latam masimo com Masimo Middle East Middle East Tel 962 6 4886641 Masimo Nederland Tel 31 135 832 479 Masimo International Sari Tel 41 32 720 11 55 Tech Services techserviceeu masimo com International Headquarters Masimo Europe Espafia Tei 34 91 8049734 Masimo International S rl Tek 41 32 720 11 66 UK Masimo UK Tel 44 0 1256 479988 2 of 3 MAS Please be assured that Masimo Corporation is committed to consistently providing high quality products and services to our customers We apologize for any inconvenience this
62. agen of hulp nodig heeft bij deze kennisgeving inzake veiligheid neem dan contact op met uw plaatselijke vertegenwoordiger Hoogachtend Sandra Hassler Quality Department Boston Scientific International S A Bijlage Verificatieformulier Page 2 of 2 Sold_to CP Hospital Name Users Name Department Customer Address Zip Code City Country name R f rence Notification 90748268 FA xx mars 2012 Notification d information de s curit Retrait urgent de dispositif m dical Aiguille droite Soloist M Users Name Boston Scientific proc de au retrait du dispositif m dical d nomm aiguille droite Soloist M utilis lors de proc dure de radiofr quence Suite un contr le interne nous avons constat que les dates d expiration de l aiguille droite Soloist sont incorrectes En effet les dates d expiration indiqu es sur l lectrode 20 ans et sur le conditionnement externe 5 ans excedent la date d expiration appropri e qui est de trois ans Cette erreur d tiquetage ne devrait entrainer aucun pr judice tant donn que tous les lots list s ci dessous n ont pas d pass la date d expiration de trois ans D apr s nos informations votre tablissement a recu des produits concern s par cette communication Le tableau ci dessous pr sente une liste compl te de tous les produits concern s avec la description du produit la r f rence du mat riel UPN num ro de produit u
63. aider appliquer cet Avis de s curit volontaire l intention des utilisateurs si vous demandez une assistance Transmission de l avis de s curit D apr s notre base de donn es il a t d termin que vous avez recu l un des produits figurant l annexe 1 Partagez cette lettre avec tous les membres du personnel de votre tablissement qu elle concerne Si vous avez des questions ou souhaitez un compl ment d informations sur ce bulletin vous pouvez contacter votre Product Specialist Nous vous pr sentons nos excuses pour les d sagr ments que cela pourra vous causer permettez nous de vous assurer que nous ferons tout ce qui est en notre pouvoir pour vous faciliter la t che Informations suppl mentaires Le 9 juillet 2012 ASP commencera exp dier les indicateurs biologiques IB STERRAD CYCLESURE 24 arborant des dates de p remption justes qui ne n cessitent aucune conversion Les clients pourront distinguer les produits actuels des produits nouvellement exp di s gr ce au num ro de lot e Le produit actuel a un num ro de lot contenant six 6 caract res par ex 123456 e Le produit nouvellement exp di aura un num ro de lot compos de huit 8 caract res par ex 123456EE Nous vous prions d agr er ch re Madame cher Monsieur l assurance de notre consid ration distingu e Johnson amp Johnson Medical S A F M JJ Reijntjens Quality Manager Benelux Ziekenhuis T a v Farmacie Straat Po
64. ards al v D Lehne Dr R Bachus Vice President MR Technology amp Research Systems Vice President Quality Management Business Unit Magnetic Resonance Business Unit Magnetic Resonance Siemens AG Healthcare Sector Siemens AG Healthcare Sector SCF 04 2011 V08 12 Page 2 of 2 SI EM ENS Healthcare Siemens nv Marie Curiesquare 30 1070 Brussel Belgi Naam Geert Roose Divisie Customer Service Division AANGETEKEND Etablissement el Nom Fax 02 536 46 74 Fonction GSM Rue E mail marion wesendonk siemens com Ville Uw referentie Onze referentie HIM GR mw R 16456 Datum 15 oktober 2012 Veiligheidsadvies betreffende MAVIG PORTEGRA 2 systemen in combinatie met Siemens radiografie installaties Formule Tijdens een kwaliteitscontrole is gebleken dat bij de installatie van het MAVIG PORTEGRA 2 systeem mogelijk een component niet geplaatst werd Gezien dit stuk niet actief betrokken is bij de werking van het MAVIG PORTEGRA 2 systeem heeft het ontbreken ervan in principe geen impact op de functionaliteit Het stuk dient ervoor om een pin tegen te houden in het geval dat deze zou loskomen Deze pin verhindert dat er speling tussen bepaalde elementen optreedt waardoor de werking van het systeem belemmerd zou kunnen worden Verder zouden de betroffen elementen mogelijk volledig kunnen loskomen Dit probleem betreft de MAVIG PORTERA 2 systemen met de volgende Siemens artikelnummers 7721165 478771
65. bject to Zimmer Inc Urgent Correction Notice for the NexGen Cruciate Retaining CR Micro Articular Surface Compatibility Printed Name Signature Date Hospital Name Hospital Address Complete and return to national QA RA Zimmer department Baxter Xx Avril 2012 Madame Monsieur Produit affect Description du probleme Risque potentiel Comment identifier les produits affect s Actions suivre par le client Actions planifi es par Baxter NOUVELLE INFORMATI ON IMPORTANTE En accord avec l Agence F d rale des M dicaments et des Produits de Sant Baxter souhaite vous informer d un probl me associ la version francaise du Guide du Patient Domicile pour les systemes de DPA HOMECHOICE HOMECHOICE PRO 07 19 64 016FRE Plusieurs erreurs de traductions ont t identifi es dans la version francaise du Guide Patient HOMECHOICE Ces erreurs sont list es dans le tableau 1 ci joint Les effets potentiels de ces erreurs de traduction sont galement d crits dans le tableau 1 ci joint Aucun effet ind sirable relatif ces erreurs de traductions n a t rapport Baxter Les Guides du Patient Domicile impact s pour les syst mes de DPA HOMECHOICE HOMECHOICE PRO sont r ference s 07 19 64 016FRE et la date du 17 Mars 2011 est mentionn e sur la page de couverture Nous vous remercions de bien vouloir garder cette communication avec votre Guide du Patient Domicile jusqu
66. ccur Very specific conditions in the workflow will need to have occurred to observe this error 1 image with a Revolution catheter and a PIMr 1 5 AND 2 Userthen selects a Field of View FOV other than the system default of 8mm diameter AND 3 The PIMr then experiences an over spin overcurrent condition caused by the catheter rotation stalling briefly for less than two 2 seconds leading to the PIMr resetting itself Rotational stalls can occur if there is pressure applied to the catheter connection or rotational resistance is encountered during imaging A stall of two 2 seconds or longer will cause the system to go into a Catheter Fault error which will result in the system correcting itself How To Avoid The Error If you do not change the FOV from the system default 8mm diameter the error cannot occur if possible you should only use 8mm FOV until the software patch is deployed If you must change the FOV and you believe an error has occurred see section below for detection of the error then disconnect the PIMr reconnect it and re image Per normai practice confirm your measurements with those images acquired by angiography as directed by the Instructions for Use How to Detect the Error Pay attention to the following indicators as this error is easily detected by one or all of the following visual cues Please refer to image 3 which shows how the easily the issue can be detected e The quality of the image is significantl
67. ct you to schedule an upgrade of your MMG and or Cardiomax The MMG shall be updated to software version 3 02 and Cardiomax to 4 00 at the customer site Ascom Sweden AB Wireless Solutions P O Box 8783 SE 402 76 G teborg T 46 31 559300 F 46 31 552031 Org nr F skatt 556336 6292 VAT No SE556336629201 REG Office GOTEBORG www ascom com Page 1 ascom Please note that the intended use of Ascom Cardiomax and software is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device s and that Ascom Cardiomax and MMG software 15 intended for use as a secondary alarm It does not replace the primary alarm function on the monitor Follow up of implementation will be done by Ascom Sweden AB within 60 days after the release of this notice In case of questions please contact Ascom Sweden AB Wireless solutions Contact person Tania Ottebrink Tania ottebrink ascom se 46 31 55 93 00 Tania Ottebrink VP and Director Division Quality R amp D Manager Product Configuration amp Conformity Ascom Sweden AB Wireless Solutions P O Box 8783 SE 402 76 G teborg T 46 31 559300 F 46 31 552031 Org nr F skatt 556336 6292 VAT No SE556336629201 REG Office GOTEBORG www ascom com Page 2 SI EM ENS Healthcare Siemens SA Square Marie Curie 30 1070 Bruxelles Belgique Nom R Reijn Division Customer Service Division RECOMM
68. de st rilisateurs ci dessus list s mod les M11 fabriqu s de 1994 2003 quip s d un affichage LED de couleur rouge Midmark a d cid la mise en uvre de cette action corrective apr s avoir t inform de quelque rares cas de fermeture incompl te de la porte avant la mise en service du dispositif Les illustrations suivantes indiquent la localisation des N de s rie et la r f rence du mod le sur l unit Model Number BACK of sterilizer Nota Le N se s rie est galement mentionn a l int rieur de la porte si l acc s a l arri re de l appareil se r v le difficile Les N de s rie concern s par cette op ration d butent par les pr fixes suivants ES ET FP FH GB GC GD amp NP Page suivante Le sticker additionnel d avertissement est apposer par l utilisateur final proximit de la poign e de porte comme indiqu e ci apr s Celui ci constitue un rappel pour l utilisateur de bien respecter les instructions du manuel d utilisation disponibles galement sur Midmarks Technical Library sur le site www Midmark com afin de s assurer que la porte est correctement verrouill e en position ferm e avant toute utilisation Une fois cette op ration r alis e nous demandons aux utilisateurs finaux de compl ter le formulaire inclus et le retourner Midmark lls peuvent galement compl ter ce formulaire en ligne sur www midmark com FCAResponse Cette proc dure doit imp rativement
69. document Tables 1 and 2 It is important to conform to the NexGen compatibility chart and package labeling for all combinations of available femoral components tibial components and polyethylene articular surfaces for the NexGen CR implant system The compatibility chart and labeling correctly reflects the approved combinations of available femoral components tibial components and polyethylene articular surfaces for the NexGen CR implant system Please refer to the attached NexGen CR Compatibility Chart Figure 1 for detailed information The following is a summary of certain key information contained in that chart e Solid purple CR articular surfaces should not be used with standard CR femurs e Solid purple CR articular surfaces should only be used with A B Micro Femurs that are compatible with 1 2 Tibias e Striped yellow CR articular surfaces should not be used with standard CR femurs e Striped yellow CR articular surfaces should only be used with A B Micro Femurs that are compatible with 3 4 Tibias e Outside US micro femurs may be available in sizes C E thus micro articular surfaces may be used with micro surfaces A through E Zimmer NexGen Knee Cruciate Retaining CR CRA and CR Flex Fixed Femoral Size d ous YAN SD GREEN Use micro size patellas with A B micro size femoral components zemm inset only 29mm Patella Size Use standard size patellas with C H standard femoral components 26mm inset only 29mm
70. e GVL 5 Artikelnummer Serienummers 0574 0030 XL105000 tot XL111798 De bladen in deze productiebatches lopen een verhoogd risico op stress breuk welke zich ontwikkelt in de tip van het blad Het is mogelijk dat dit probleem verborgen blijft bij routine inspectie voorafgaand aan intubatie Een materiaalbreuk zou ertoe kunnen leiden dat het product ongeschikt is voor het daartoe bedoelde gebruik Tot op heden zijn er geen berichten bij Verathon binnengekomen waarin verwondingen aan pati nten gerapporteerd zijn Door een herzien ontwerp en productieproces geimplementeerd in augustus 2011 is het genoemde probleem ge limineerd Verathon heeft het ontwerp van de laryngoscoopbladen aangepast zodat een worst case scenario waarin drukverschillen tussen samenstellende onderdelen van het blad welke incidenteel tot hoge interne spanningen kunnen leiden en zich tot een breuk kunnen ontwikkelen niet meer kan optreden Ten einde de beschikbaarheid van uw GlideScope systeem niet in gevaar te brengen zal Verathon de betreffende bladen kosteloos vervangen waarbij voor het vervangende blad weer een garantieperiode van n jaar zal gelden Mocht u nog vragen hebben betreffende deze terugname dan kunt u contact opnemen met de Customer Care afdeling van Verathon Medical op the telefoonnummer NL 31 030 68 70 570 De terugname wordt uitgevoerd in volledige bekendheid met de relevante Nationale Competente Autoriteit voor Medische Producten Gelieve en
71. e Particle catalogue REF REF STAND F O LED LARYN GR 2 5V F 008 22 860 FLEXTIP LED LARYNGOSC SET FT3 F 227 28 865 STAND F O LED LARYN GR 3 5V F 008 22 863 F O LARYNG SET MAC MODULAR F 228 18 860 HRA 52 039 M nchen Heine Optotechnik Verwaltungs GmbH Herrsching HRB 45192 M nchen Gesch ftsf hrer Dipl Kfm Helmut M Heine Oliver Heine BA WEEE Reg Nr DE 87119271 Interne ID 15 2012 02 15 FR FSN HEINE HEINE Optotechnik GmbH amp Co KG Kientalstr 7 82211 Herrsching Germany Tel 49 0 8152 38 0 Fax 49 0 81 52 38 202 E Mail info heine com www heine com Num ro de Num ro de D signation de l article catalogue D signation de l article catalogue EF CHARGEUR LARYN STAND FOL LED Descriptif du probl me et de l identification de son origine Quelques incidents isol s nous ont t rapport s concernant l utilisation de l insert de batterie LED des poign es de laryngoscope standard F O HEINE indiqu plus haut Une d faillance de l clairage pouvait entrainer le fait qu une intubation devait tre repouss e ou que celle ci ne pouvait m me pas tre r alis e si d autres appareils ou dispositifs de s curisation des voies respiratoires n taient pas disponibles ou trop tardivement Les batteries concern es peuvent pr senter dans de rares cas des probl mes de contact lorsqu elles sont utilis es avec des cellules premi res piles de certains fabricants Nous avons p
72. e en acier par l orifice de nettoyage situ sur la tige du manche Dispositifs concern s par ce rappel R f rence Description du produit D tails UMH700 RUMI ARCH CHAQUE manche doit tre renvoy UMH750 Advincula Arch Seuls les manches dont le num ro de s rie est inf rieur 1204001 ou compris entre 11110010 et 11110069 doivent tre renvoy s Nos dossiers indiquent qu un ou plusieurs de ces dispositifs vous ont t exp di s Veuillez prendre contact avec l ensemble de vos clients ayant ces manches en leur possession et faire en sorte qu ils soient remplac s dans les plus brefs d lais Veuillez contacter notre service client au 1 203 601 9818 la premi re invite appuyez sur 1 la seconde appuyez de nouveau sur 1 Des dispositions seront prises pour remplacer le produit en votre possession aux frais de CooperSurgical D autres instructions ainsi que les mesures d limination du produit vous seront communiqu es directement ce moment l En outre nous vous serions tr s reconnaissants si vous pouviez remplir le formulaire ci joint de Demande de remplacement de produit rappel et l envoyer par t l copie CooperSurgical Inc l attention du service Clients internationaux International Customer Service au 1 203 601 4747 82253d 11 12 CooperSurgical est sinc rement d sol des d sagr ments caus s par ce probl me Je vous prie de croire l assurance de mes salutations distin
73. e hieronder vermelde lotnummers nog binnen de uiterste gebruiksperiode van drie jaar vallen Onze gegevens tonen aan dat uw instelling een aantal van de betrokken producten heeft ontvangen De tabel hieronder toont de complete lijst van de bij deze retouractie betrokken producten onder vermelding van productomschrijving materiaalnummer UPN lotnummers Let op alleen de materiaalnummers en lotnummers genoemd in onderstaande tabel zijn betrokken Geen enkel ander Boston Scientific product is betrokken bij deze vrijwillige kennisgeving veiligheid Materiaal Materiaal nummer UPN nummer UPN Productbeschrijving Artikelnummer Artikelnummer Lotnummers voor de voor de buitenverpakking binnenverpakking SoloistTM Single Artikelnummer 14386589 14435130 14578709 14629530 14715963 Needle Electrode M001262500 1 1 binnenverpakking 18cm outer box zie hieronder 14722621 14776399 14805361 Artikelnummer 14383536 14432173 14581820 14625649 14715972 Soloist Electrode Power Cord buitenverpakking M001262510 zie hierboven 14722622 14775117 14805368 SoloistTM Single Artikelnummer 14383537 14434176 14581821 14625651 14715971 Needle Electrode buitenverpakking M001262520 18cm inner pouch zie hierboven 14722623 14775116 14805362 imer Page 1 of 2 Sold_to CP AANWIJZINGEN l U dient het gebruik van alle hierboven vermelde Boston Scientific productpartijen onmiddellijk te staken en alle betro
74. e maintenance de routine MR dans un d lai de 12 mois Dans le cas des pays o la revalidation n est pas planifi e annuellement veuillez contacter votre repr sentant ASP local pour un compl ment d information Nous vous prions d agr er ch re Madame cher Monsieur l assurance de notre consid ration distingu e Johnson amp Johnson Medical S A F M J Reijntjens Quality Manager Benelux Ziekenhuis T a v Directie Straat Postcode Plaats Diegem 3 december 2012 Ref FMJRI 12 38 AASP05 2012 VEILIGHEIDSBULLETIN Uitbreiding actie Update CycleSure 24 Biological Indicator Geachte heer mevrouw Product Het probleem betreft de volgende productcodes en lotnummers REF 14324 STERRAD CycleSure 24 Biological Indicator REF 14325 STERRAD CYCLESURE 24 Test Pack REF 20239 STERRAD NX Test Pack REF 20243 STERRAD 100NX International Test Pack REF 20123 STERRAD 100NX EXPRESS Cycle Test Pack REF 20232 STERRAD 50 1005 Sterilizer CYCLESURE 24 Validation Kit REF 20233 STERRAD 200 Sterilizer CYCLESURE 24 Validation Kit REF 20253 STERRAD NX Validation Kit REF 20228 STERRAD 100NX Validation Kit REF 20248 STERRAD 100NX EXPRESS Cycle Validation Kit Zie bijlage 1 voor de betreffende lotnummers Betrokken lotnummers alle lotnummers gefabriceerd tussen februari 2008 en december 2011 Probleem De vervaldatum komt mogelijk niet overeen met de gegevens in de ASP documentatie Advanced Sterilization Products ASP heeft onlangs vastg
75. e of Device Orthopaedic Implants manufactured by Zimmer GmbH Winterthur Switzerland prior to March 2010 Notification Zimmer GmbH is initiating this Field Safety Corrective Action to inform customers with consignment to check patient labels against product labels during the surgery for products manufactured by the Zimmer GmbH production site in Winterthur Switzerland before March 2010 Figure 1 presented below provides an example of a representative product label which indicates the Zimmer GmbH production site following the dark production plant symbol and also indicates the production date following the white production plant symbol In rare cases product information on the patient label with respect to REF number LOT number might not coincide with the corresponding information on the product label While the information printed on the product label is always correct the information on the patient label in rare cases may be wrong Please note that although it is unlikely that lots in your consignment delivered to you with manufacturing date prior to March 2010 are affected we are issuing this letter as preventative information Page 1 of 3 Zimmer GmbH P O Box CH 8404 Winterthur Phone 41 0 52 262 60 70 Fax 41 0 52 262 03 64 www zimmer com NOS Ro gx Td 5 i sid me ttam trem sas ds ERE moors EOt 6102001013 LoT oi 2492002 i DE Gander Salt en LOT po
76. e when a louder level is actually intended may result in an audible alarm that is more difficult to hear If this happens it is possible the clinician may not be alerted when an alarm condition occurs and an interruption in therapy may occur To determine which direction to turn the knob to change and confirm the volume level follow the directions below Before Beginning Therapy To confirm that the audible alarm volume is acceptable for the environment where the infuser will be used follow the steps below before connecting to a patient 1 Turn the pump on with a cassette installed 2 Lookatthe infuser display until the Cassette test in progress message is shown 3 During the cassette test open the cassette door The pump will alarm 4 Adjust the volume to the desired level rotating the volume control knob located on the back of the infuser until the audible volume is acceptable then close the cassette door During Therapy The alarm volume may be adjusted during any alarm condition by rotating the knob to achieve the desired LER ERE Gall level Oo 00 o M A EE Hospira The system operating manual will be updated to clarify the instructions for setting the volume Hospira will issue updated manuals as soon as they are available Furthermore Hospira will be creating a volume directional label as an additional improvement Upon development and approval of the labels Hospira will contact all customers Hospira is committed to pr
77. ecall betrokken zijn dienen de biologische indicatoren te worden teruggestuurd volgens de richtlijnen voor het retourneren in de alinea s hieronder Retourneren van producten 1 Controleer uw voorraad en retourneer alle ongebruikte STERRAD CYCLESURE 24 Biological Indicator BI producten waarvan de berekende nieuwe vervaldatum overschreden is 2 Tel alle producten in uw voorraad waarvan de berekende nieuwe vervaldatum overschreden is en noteer deze gegevens op het Field Safety Notice Check formulier 1 Vul het Field Safety Notice Check formulier in en fax het binnen 3 werkdagen terug naar tel 02 746 3001 ook als u geen producten met overschreden vervaldatum hebt Als u een product hebt dat geretourneerd moet worden bewaar dan een kopie van dit formulier voor uw eigen administratie 2 Voeg bij het retourneren van het betreffende product een kopie van het Field Safety Notice Check formulier Uw Productspecialist kan u behulpzaam zijn bij het invullen van deze vrijwillige Field Safety Notice Verzending van dit veiligheidsbulletin Dit bulletin werd u toegestuurd aangezien uit onze administratie blijkt dat u een van de producten uit bijlage 1 ontvangen hebt Wij verzoeken u dit bulletin ook door te gegeven aan iedereen die hiervan op de hoogte moet worden gebracht binnen uw organisatie Als u nog vragen heeft over dit bulletin kunt u contact opnemen met uw Product Specialist Wij bieden u onze excuses aan voor het eventueel ontstane
78. echnik GmbH amp Co KG fuf Georg Grohs Director Quality Management Interne ID 15 2012 02 15 EN FSN HEINE HEINE Optotechnik GmbH amp Co KG Kientalstr 7 82211 Herrsching Germany Tel 49 0 8152 38 0 Fax 49 0 81 52 38 202 E Mail info heine com www heine com Mai 2012 Notification de s curit urgente FSN Mesures correctives de s curit FSCA concernant Le boitier piles insert LED des poign es de laryngoscope Standard F O avec illumination LED HEINE A Pattention des revendeurs sp cialis s en technique m dicale des responsables des techniques m dicales des services administratifs hospitaliers des services de technique m dicale des services d anesth sie Identification des produits m dicaux concern s Bo tier piles LED sans culot Num ro de REF F 008 22 890 catalogue HEINE 1230009124 Num ro de s rie Sont concern s par ces mesures correctives tous les inserts de batterie de LED portant les num ros de s rie 1230000000 a 1230999999 Les appareils concern s ont t fabriqu s dans la p riode du 12 02 2010 au 15 09 2011 Ne sont pas concern s par ces mesures les inserts de batterie LED dont le num ro de s rie commence par 1231 ou 1232 Veuillez noter que les bo tiers piles a LED sont vendus aussi bien s par ment que d ja inclus dans les articles suivants Num ro de Num ro de D signation de Particle catalogue D signation d
79. egarding the devices here above mentioned Problem description The Polysite Echo kit includes e Polysite kit One implantable catheter port and its accessories e One ultrasound gel The Expiry date of the POLYSITE ECHO kit is correct linked to the shorter expiry date that is to say the ultrasound gel s one Si ge social Divisions Oncologie Divisions Imagerie Route du Manoir amp Cardiovasculaire Interventionnelle amp BtoB 60173 Ivry le Temple France Route du Manoir 135 Route Neuve consent ae gt Pm T l 33 0 3 44 08 17 00 60173 Ivry le Temple France 69540 lrigny France ni m Fax 33 0 3 44 08 17 01 T l 33 0 3 44 08 17 00 T l 33 0 4 72 39 74 14 Fax 33 0 3 44 08 17 01 Fax 33 0 4 78 51 89 67 ONO gt Case of the 3008ECHO reference An incorrect expiry date has been found on the POLYSITE batch 12071189 included inside the POLYSITE9 ECHO kit batch 12081141 This device is labeled with an expiry date July 2012 whereas it should have been labeled with an expiry date July 2017 as it has been sterilized in August 2012 see below example gt Case of the 3017ECHO reference An incorrect expiry date has been found on the POLYSITE batch C009532 included inside the POLYSITE ECHO kit batch C009726 This device has been labeled with an expiry date June 2011 whereas it should have been labeled with an expiry date June 2016 as it has been sterilized in July 2011 P
80. egistered in England No 1923357 URGENT FIELD NOTICE REPLY FORM 11005 11971 12391 20792 Section Hospital Facility Details Please fill out the information below and fax the completed form to Hospira at local fax number 29 October 2012 Section have read and understood the contents of this Field Action circulated it to all staff departments that use this product and confirm that our inventory has been checked and we have no inventory of the listed products OR Section C have read and understood the contents of this Field Action and circulated it to all staff departments that use this product Section D Please indicate the number of System Operating Manuals at your location Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW United Kingdom Telephone 44 0 1926 820 820 E 5 0 1990 535 200 Rn www hospira com Registered in England No 1923357 Plum A Family of Infusers OLYMPUS Your Vision Our Future Aartselaar le mardi 15 Janvier 2013 LETTRE DINFORMATION Conseil de S curit QIL145 006 Rappel sur le nettoyage et la d sinfection du duod noscope TJF Q180V Cher client Suite un cas r cemment rapport de contamination d un Vid o Duod noscope TJF Q180V Olympus nous souhaitons attirer votre attention sur les points suivants e Suivre pr cis ment toutes les instructions du manuel de traitement du TJF Q180V e
81. ements with those images acquired by angiography as directed by the Instructions for Use A 1 Look for FOV in right corner tf 10mm adjust with arrows in location circled Volcano Corporation Page 2 of 5 August 2012 VOLCANO D Pay attention to the following indicators as this error is easily detected by the following visual cues Please refer to Image 2 which shows how easily the issue can be detected e The graticules shift from the defined FOV back to the normal default FOV e The first graticules from the center are not aligned with the edge of the catheter mask Once the errors have occurred any images captured in a Video Loop or Still Frame cannot be corrected Affected Video Loops or Still frames can be detected by verifying whether the first graticules are aligned with the edge of the catheter mask Refer to Image 2 _Image 2 Catheter Mask m Image before error Image after error muse om g A ger Be Volcano Corporation Page 3 of 5 August 2012 MVOLGANO 2 ROTATIONAL IVUS CATHETER ERROR We have identified a similar error with our Rotational IVUS catheter This only occurs under very specific conditions which manifests into easily identifiable visual cues It has been reported once from the field and was immediately detected by the user This issue can appear only with the Revolution 45MHz IVUS Imaging Catheter Under What Conditions Can the Error O
82. er the blue black physician input device in the control room continually sent an advance command to the system without physician input Without intervention the Vdrive advanced catheter body until the catheter handle reached the advancer unit While the observed hazard involved a specific faulty physician input device Stereotaxis has no proof that this failure could not be reproduced elsewhere e If this behavior is observed in a procedure catheter advancement will be stopped by withdrawing the catheter by a variety of methods including pulling back on the controller knob Additionally all Vdrive control can be stopped by pressing the red emergency E stop button Contact your local Stereotaxis representative e Resolution Stereotaxis has created new software Navigant 4 3 1 to prevent this hazard in future The software will begin installations in the coming weeks e Similar but unaffected devices Note that this hazard does not impact magnetic catheter advancement using the QuikCAS CardioDrive device Furthermore this hazard does not apply to Vdrive control of sheaths circular pulmonary vein catheters or intracardiac echo catheters as these devices all have maximum extension limits As a part of our documentation of this hazard Stereotaxis needs documentation that a hospital representative has been notified of the situation Please sign this document and email a copy of the document Hospital print Name print Title print Signat
83. erdere informatie m b t de vereiste stappen vindt u in Hoofdstuk 3 Voorbereiding en Inspectie van de Gebruikershandleiding van de TJF Q180V Bijkomende exemplaren van de Gebruikershandleiding of van de bovenvermelde Reinigingshandleiding zijn steeds verkrijgbaar Gelieve deze informatie aan alle betrokken personen binnen uw organisatie te verstrekken Wij zijn ervan overtuigd dat bijgevoegde informatie u van dienst zal zijn Mocht u nog vragen hebben of wenst u een bijkomende opleiding m b t onderhoud van uw Olympus TJF Q180V gelieve uw Olympus vertegenwoordiger te contacteren die u graag verder zal helpen PS voor opvolging binnen ons kwaliteitssysteem gelieve bijgevoegd antwoordformulier op keerzijde ons terug te bezorgen Met vriendelijke groeten E ir Koen Waelput Serge Hopchet Quality Manager Division Manager Medical Systems OLYMPUS BELGIUM N V Boomsesteenweg 77 B 2640 Aartselaar Tel 32 0 3 870 08 O Fax 32 0 3 887 24 25 www olympus be Deutsche Bank Brussels 826 0004292 41 IBAN BE88 8260 0042 8241 BIC DEUTBEBE RPR RPM Antwerpen B T W T V A BE0405 804 052 OLYMPUS Your Vision Our Future ANTWOORDFORMULIER Ref QIL 145 006 Onderwerp Belangrijk Veiligheidsadvies betreffende de Reiniging en Desinfectie van de video duodenoscoop TJF Q180V Gelieve dit formulier terug te sturen naar OLYMPUS BELGIUM NV ir Koen Waelput Boomsesteenweg 77 B 2630 Aartselaar FAX 32 3 887
84. ervaldatum overschreden is 2 Tel alle producten in uw voorraad waarvan de berekende nieuwe vervaldatum overschreden 15 en noteer deze gegevens op het Field Safety Notice Check formulier 1 Vul het Field Safety Notice Check formulier in en fax het binnen 3 werkdagen terug naar tel 02 746 3001 ook als u geen producten met overschreden vervaldatum hebt Als u een product hebt dat geretourneerd moet worden bewaar dan een kopie van dit formulier voor uw eigen administratie 2 Voeg bij het retourneren van het betreffende product een kopie van het Field Safety Notice Check formulier Uw Productspecialist kan indien behulpzaam zijn bij het invullen van deze vrijwillige Field Safety Notice Verzending van dit veiligheidsbulletin Dit bulletin werd u toegestuurd aangezien uit onze administratie blijkt dat u een van de producten uit bijlage 1 ontvangen hebt Wij verzoeken u dit bulletin ook door te gegeven aan iedereen die hiervan op de hoogte moet worden gebracht binnen uw organisatie Als u nog vragen heeft over dit bulletin kunt u contact opnemen met uw Product Specialist Wij bieden u onze excuses aan voor het eventueel ontstane ongemak maar u kunt ervan verzekerd zijn dat wij er alles aan zullen doen om dit proces voor u zo gemakkelijk mogelijk te maken Extra informatie Op 9 juli 2012 zal ASP beginnen met de leverantie van STERRAD CYCLESURE 24 Biological Indicator BI producten met de juiste vervaldata die niet gewijzigd hoeve
85. es Department who have been contacted regarding this matter Signed Print Name Position Organisation Hospital Date VOLCANO IMPORTANT FIELD CORRECTIVE ACTION Re Volcano s5 s5i Family Software Version 3 2 1 3 2 2 August 30 2012 Dear Sir Madame We are writing to inform you of an extremely remote event that may occur when using the Volcano s5 sSi Imaging System when running either software version 3 2 1 or 3 2 2 Under very specific and remote conditions two software display errors may occur in the 3 2 X Intravascular Ultrasound IVUS software when used with Digital IVUS Catheters except PV 018 and PV 8 2 and the Rotational Revolution 45 MHz Catheter The software display errors do not occur in the Digital IVUS Catheters if the normal default of 10mm Field of View FOV is used and in the Revolution Catheter if the system default of 8 mm FOV is used If the software errors occur the display will be shifted to a different FOV and will differ from the angiographic data if the user fails to compare the displayed data to the angiographic data as required by the Instructions for Use IFU the issue may be overlooked leading to a possible error in vessel sizing with a moderate potential for restenosis or the potential placement of an additional stent The In Line Digital ILD measurements VH IVUS ChromaFlo and Fractional Flow Reserve FFR measurements are not affected Volcano is developing a software patch to
86. es Mandible Distractor mulitaxial This action is being initiated following a detailed investigation in response to a reported complaint of missing outer sheer pin The inner diameter for fixing the sheer pin of the worm gear component was out of specification For patients who may be undergoing treatment with this device it is advised to contact the patient to check if the device they have is one of the effected lots If the patient is in the consolidation phase of treatment a consolidation rod should be used according to the Surgical Technique page 13 If the patient is in the distraction phase of treatment and has one of these device lots please follow the steps on page 13 of the Surgical Technique Guide which describes the application of a consolidation rod and removal of the device Once the central body of the device has been removed as described a new device can be put in its place and secured The distraction arms can be preloaded by normal activation The consolidation rod can then be removed To eliminate any risks Synthes decided to remove all potential affected parts from the field oynthes is requesting that you immediately cease using the product and please examine your inventory for the above effected lot numbers and remove them When in doubt please remove the product and provide it to your Synthes Sales Representative Thank you for your attention and cooperation oynthes GmbH Heinz Gribi Markus Wien Manager Compla
87. es salutations HEINE Optotechnik GmbH amp Co KG fuf Georg Grohs Directeur Qualit HRA 52 039 M nchen Heine Optotechnik Verwaltungs GmbH Herrsching HRB 45192 M nchen Gesch ftsf hrer Dipl Kfm Helmut M Heine Oliver Heine BA WEEE Reg Nr DE 87119271 Interne ID 15 2012 02 15 FR FSN Urgent Field Safety Notice SILENTIA SCREEN SYSTEM Date 2012 06 26 Products affected All products in Silentia screen system Type of action Change to instructions for use Background A problem can occur when certain models of beds have parts that project beneath the screen when the bed is in the lowered position If these parts rise when the bed is raised there is a risk that the bed can lift the screen up with excessive force and damage its mountings This could cause the screen to detach and fall over The screen may fall over immediately or when someone moves it or uses it at a later time Screens have fallen over a few times over the past year for this reason Although no one has been injured as a result we have decided to add the warning shown below to the instructions for use The risk is considered greatest with beds that can be raised and lowered electrically Advice for users Users are asked to take note of the following warning in the instructions for use Before you raise a bed that is close to the screen make sure that no part of the bed projects beneath the screen The powerful lifting action of the bed can dama
88. esteld dat er onvoldoende gegevens zijn om de producten over de gehele op het etiket vermelde houdbaarheidsperiode te kunnen garanderen Daarom verzoekt ASP de cli nten om de STERRAD CYCLESURE 24 Biological Indicator BI uit hun voorraad te nemen en de houdbaarheid van al deze producten te vergelijken met de gewijzigde houdbaarheidsperiode volgens de instructies in de alinea MAATREGEL hieronder Het gebruik van STERRAD CYCLESURE 24 Biological Indicators BIs met lotnummers zoals vermeld in bijlage 1 dient direct te worden gestaakt Wij vragen onze cli nten om de betreffende producten te retourneren Ofschoon het risico op infectie voor een individuele pati nt gering is aangezien de biologische indicator slechts een van de middelen is waarmee een sterilisatieproces wordt gevolgd kunt u bij het gebruik van de lotnummers van bijlage 1 mogelijk de juiste sterilisatiecondities niet controleren Te ondernemen actie Wij hebben uw hulp nodig om ervoor te zorgen dat alle betreffende producten worden gelokaliseerd en volgens de volgende instructies worden gehanteerd PER DIRECT VAN TOEPASSING Controleer het lotnummer op de verpakkingen van STERRAD CYCLESURE 24 Biological Indicator BI zie afbeelding 1 en raadpleeg de bijlage 1 voor de betrokken lotnummers Ox 106 CFU each soc Lot Number Als u STERRAD CYCLESURE 24 Biological Indicators BI heeft verpakt per doos of deel uitmakende van een testpakket die bij de r
89. et de contr ler chaque boite par rapport aux instructions nonc es dans la section Quelle action est requise ci dessous Tous les clients doivent cesser d utiliser les produits issus des lots d indicateurs biologiques STERRAD CYCLESURE 24 identifi s dans l Addendum 1 ci joint et renvoyer le s produit s concern s conform ment aux Instructions concernant le retour des produits ci dessous Bien que le risque d infection pour un patient soit minime l indicateur biologique n tant qu un des trois dispositifs de contr le des syst mes de st rilisation l utilisation d un produit provenant des lots identifi s dans l Addendum 1 ci joint risque de rendre la v rification de conditions de st rilisation ad quates impossible Action Nous avons besoin de votre aide pour nous assurer que tous les produits concern s sont localis s et trait s conform ment aux instructions suivantes ENTR E EN VIGUEUR IMM DIATE Contr lez le num ro de lot imprim e sur l emballage des boites et sur ses composantes indicateur biologique IB STERRAD CYCLESURE 24 comme le montre la Figure 1 Dans l annexe 1 vous trouverez la liste des num ros de lot incrimin s Lot Number Si vous d couvrez indicateurs biologiques STERRAD CYCLESURE 24 incrimin s emballez la boit ou part de kit de test le produit doit tre retourn imm diatement selon les Instructions de retour du produit figurant ci dessous Marche suivre p
90. eta Cap Adapter09 12 ItemCode 8810887003 8810888003 8810888012 8810889003 8810889011 8810890003 8810890014 8811313009 8811313010 8811313013 8811313014 8811313015 8812321001 8812329001 8812329002 8814843001 8814843002 8815677001 8817278001 8817278006 8817278007 8817278008 8888285001 8888410506 8888410514 8888411009 8888411405 8888411421 8888411439 8888411447 8888411702 8888411710 8888412007 8888412015 8888412023 8888412601 8888412619 8888413005 8888413013 Peritoneal Dialysis Catheter Product Description STRT TENCKHOFF LOOSE CUFFS 42CM X1 STRT TENCKHOFF 2 CUFFS 42CM X1 TENCKHOFF STRT CATH UNIV 47CM X1 SUBCUT PSTION STRT 42CM X1 SUBCUT 46CM STRT TENCKHOFF X1 STRT PD TENCKHOFF 2 CUFFS 37CM X1 STRT PD TENCKHOFF 2 CUFFS 32CM X1 CRL CTH W LOOSE CUFFS 62CM X1 PERIT CURL 62CM TWO CUFFS X1 CURL CATH 1 CUFF 60CM X1 CURL CATH 1 CUFF 56 5CM X1 PERIT CURL 57CM TWO CUFFS X1 SUBCUT STRT PED TENCKHOFF 37CM X1 TENCKHOFF SUBCUT STRT NEONAT 31CMX1 STRT NEO TENCKHOFF 2 CUFFS 31CM X1 STRT TENCKHOFF 1 CUFF 41CM X1 STRT TENCKHOFF 1 CUFF 46CM X1 PED CURL CATH 39 25 1 CUFF X1 ACUTE PERIT DIALYSIS KIT X5 CURL CATH PERIT KIT 62CM X5 CURL CATH PERIT KIT 57CM X5 STRT TENCKHOFF PERIT KIT 42CM X5 PERI PATCH REPAIR KIT 71 X1 SN TENCKHOFF L PED SP2 LT X1 SN TENCKHOFF R PED SP2 RT X1 OREOP ZELLERMAN OZ TWH99 DBC2 X1 TENCKHOFF T202 X1 TENCKHOFF T201 Q X1 TENCKHOFF T201 X1 TENCKHOFF T202 Q X1 COLLCATH C CA2 X1 COLLC
91. etaining CR Micro Articular Surface Size Striped Yellow 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 9mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow A E Micro 20mm Height Part Number 00 5972 031 09 00 5972 031 10 00 5972 031 12 00 5972 031 14 00 5972 031 17 00 5972 031 20 00 5976 031 10 00 5976 031 12 00 5976 031 14 00 5976 031 17 00 5976 031 20 00 5970 031 23 00 5972 031 23 00 5976 031 23 Description NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 9mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 14mm Height NexGen Cruciate Retaining CR Micro Art
92. g tot de achterkant van de eenheid te krijgen Serienummers met betrekking tot het terugroepen hebben de volgende voorvoegsels aan het begin van het serienummer ES ET FP FR GB GC GD amp NP Het extra label is een waarschuwingslabel die door de eindgebruiker op de plaats naast de deurhendel geplakt moet worden zoals aangegeven in de bijgevoegde illustratie Het waarschuwingslabel zal als een herinnering dienen aan de eindgebruikers om de correcte instructies op te volgen zoals deze vermeld staan in de bedieningsgids die men kan vinden in de Midmark s Technical Library Technische Bibliotheek van Midmark op www Midmark com om ervoor te zorgen dat de grendel van de deur in de correcte gesloten positie is alvorens de bovenvermelde modelnummers te bedienen Nadat het label opgeplakt is verzoeken we de eindgebruikers om de bijgevoegde Corrigerende Praktijkactie Field Corrective Action Retour Antwoordformulier in te vullen en retour te zenden naar Midmark zoals aangegeven in de instructies Of bezoek www midmark com FCAResponse en vul het antwoord online in Het aanbrengen van deze extra labeling wordt als een corrigerende praktijk beschouwd en we werken samen met de Food and Drug Administration en de verschillende bevoegde instanties van de Europese Gemeenschap om ervoor te zorgen dat dit juist wordt uitgevoerd naar het niveau van de eindgebruiker Uw hulp wordt zeer gewaardeerd en is nodig om het ongemak voor uw klanten te beperken
93. ge the screen its accessories and or its mountings As a result the screen could fall over and cause injury to patients or staff Silentia screens can be identified by the Silentia logo near the top of the product lenie Circulating this field safety notice This field safety notice must be sent to all affected staff in your organisation and to any representatives of other organisations that have been sent products that may be affected by this risk Please fill in and photocopy where necessary the attached confirmation form and send it to your local retailer or the manufacturer within 30 days SILENTIA AB Box 108 SE 311 22 Falkenberg Sweden Tel 46 0 346 485 80 Fax 46 0 346 485 89 infoasilentia se www silentia se Org nr 556114 6902 1 3 Contact information For more information contact your local retailer or the manufacturer Manufacturer Silentia AB Box 108 SE 311 22 Falkenberg Sweden Telephone 46 0 346 485 80 Fax 46 0 346 485 89 Email qc silentia se The appropriate authorities have been informed about this safety notice We apologise for any inconvenience caused by this safety notice and hope that you understand why we have taken this action rjan Goranson CEO Attached Confirmation form SILENTIA AB Box 108 SE 311 22 Falkenberg Sweden Tel 46 0 346 485 80 Fax 46 0 346 485 89 infoasilentia se www silentia se Org nr 556114 6902 2 3 Gini Confirmation
94. gu es AOL Thomas G Williams Vice pr sident Affaires r glementaires et Assurance de la qualit des op rations F BRAINLAB ders SP Kapellenstra e 12 85622 Feldkirchen Germany phone 49 89 99 15 680 fax 49 89 99 15 68 33 FIELD SAFETY NOTICE PRODUCT NOTIFICATION Subject Cranial Navigation System Fixation of Ultrasound Adapter BK Medical might not be rigid potentially affecting the accuracy of ultrasound information displayed in navigation Product Reference 41860 35 Ultrasound Adapter BK Medical 8862 8863 Date of Notification December 5 2012 el eus Individual Notifying Julia Mehltretter amp Vigilance Manager Brainlab Identifier CAPA 20121129 000146 Type of action Device component exchange advice regarding use of device We are writing to advise you of the following potential effect Brainlab has determined for the Brainlab Ultrasound Adapter BK Medical 8862 8863 This Notification letter is to provide you with corrective action information and to inform you of the actions Brainlab is taking to address this issue Effect Brainlab Ultrasound Adapters allow you to use Ultrasound Probes for navigation with the Brainlab Cranial Navigation System For the Brainlab Ultrasound Adapter compatible with BK Medical Ultrasound transducers 8862 and 8863 the following has been detected 1 The shape of the adapter might not always allow a fixation to the Ultrasound Probe that is as rigid as requ
95. ice This Safety Advisory must be passed on to every person concerned within your organization and to every organization where the devices concerned have been forwarded This Field Safety Notice has been passed on to the Competent Authorities concerned including the French Competent Authority ANSM ASSISTANCE For any additional information please contact e Your local representative e PEROUSE MEDICAL customer service 33 0 3 44 08 17 17 e Our materiovigilance correspondent Mrs S verine VID on 33 0 3 44 08 17 68 s vide perousemedical com for any regulatory question regarding this Field Safety Notice PEROUSE MEDICAL ADDITIONAL INFORMATION The French Competent Authority ANSM has been informed of this Voluntary Field Safety Notice on October 4 2012 Please accept our apologies for any eventual inconvenience you might have Thank you for your help and your un nding PEROUSE MEDICAL FIELD SAFETY NOTICE POLYSITE ECHO TELEFLEX MEDICAL EUROPE U livieri Marco Whiriskey Crowe Una marco ulivieri teleflex com EMEARECALLS teleflex com una whiriskey crowe teleflex com Severine Vid PEROUSE MEDICAL Materiovigilance Correspondent s vide perousemedical com Date October 9 2012 Page Number 2 INVENTORY SHEET Commercial Name of the KIT POLYSITE ECHO POLYSITE device 3017ECHO Batch Number C009726 C009532 Polysite ECHO Polysite Status of the product kit Serial Number Serial
96. icular Surface Size Striped Yellow 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Striped Yellow 10mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Striped Yellow 12mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Striped Yellow 14mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Striped Yellow 17mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Striped Yellow 20mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 23mm Height NexGen Cruciate Retaining CR Micro Articular Surface Size Striped Yellow 23mm Height NexGen Cruciate Retaining CR Micro Articular Surface AC Size Striped Yellow 23mm Height Zimmer APPENDIX 1 uy Size E CR Femur Size E CR Femur Purple Micro Articular Surface Striped Yellow Micro Articular Surface o Ci gt un gt f LLJ Size C CR Femur Size C CR Femur Purple Micro Articular Surface Striped Yellow Micro Articular Surface Layouts of Various Size Combinations for Standard CR Femoral Components and Micro CR Articular Surfaces 7 Zimmer CERTIFICATE OF ACKNOWLEDGEMENT By signing below acknowledge that have received and understand the content of the letter su
97. ie over de beschikbaarheid van het product ontvangen Wij zouden het ook ten zeerste op prijs stellen als u de bijgevoegde Aanvraag ter vervanging van het teruggeroepen product invult en terugstuurt naar CooperSurgical Inc Attention International Customer Service op 1 203 601 4747 CooperSurgical betreurt het ongemak dat dit probleem heeft veroorzaakt Met vriendelijke groet AGA Thomas G Williams Vice President Regulatory Affairs and Business Assurance 0 0 24 11 1 Goper Surgical 95 Corporate Drive Trumbull CT 06611 203 601 5200 FAX 203 601 4741 31 octobre 2012 Avis de RAPPEL URGENT L ATTENTIONDE Clients utilisant le manipulateur ut rin Arch Style de CooperSurgical CONCERNE VIGILANCE UMH700 et premi res versions des manches du manipulateur ut rin UMH750 de CooperSurgical Cher client international CooperSurgical rappelle volontairement les manches de UMH700 RUMI ARCH et certaines versions de l UMH750 Advincula Arch L UMH700 a t d clar obsol te plus tot cette ann e et a t remplac par le manche Advincula Arch UMH750 gt RUMI Arch UMH 700 Advincula Arch UMH 750 Cleaning Hole Cleaning Hole Serial Number Serial Number Raison de cette action de terrain Une pression excessive exerc e sur l extr mit de l ut rus quand il est fix I Arch peut dans certaines circonstances entrainer une protrusion de la tige intern
98. ies of the type VARTA HIGH ENERGY No 4914 or by using compressed batteries There has been no reported damage to patients Nevertheless we have decided to conduct this voluntary action because the overall safety of our patients comes first Advise on action to be taken by the user 1 Please check the serial number of the LED battery inserts to determine if you have products affected by this action in your inventory 2 If there are affected products in your inventory check to see whether the equipment operates with dry cell batteries or HEINE rechargeable batteries a Foruse with dry cell batteries o Contact your local authorized dealer or supplier for a replacement free of charge o Make sure within your organization that the LED battery inserts will no longer be used o If you cannot do without the use of the laryngoscope with an affected battery LED insert before it can be exchanged by all means keep alternative measures available to secure the airway which can be used immediately in case of failure of the laryngoscope In addition conduct a functional control test before each use The light of the LED battery insert should not go out even with vigorous shaking or rapid rotation Interne ID 15 2012 02 15 EN FSN HEINE b For use with HEINE rechargeable batteries special rechargeable batteries o Contact your local authorized dealer or supplier for a replacement free of charge o date we have no reports of failure in
99. ige irregulariteit verdachte materiaaleigenschappen of incidenten gerelateerd aan de betrokken bovengenoemde productiebatches te melden bij de Verathon Medical Customer Care afdeling of de ge igende autoriteiten of instanties Wij danken u voor uw onmiddellijke attentie betreffende deze terugname Wij zijn gecommitteerd aan het leveren van de hoogste productkwaliteit en wij betuigen dan ook onze spijt voor enig ongemak dat is ontstaan Gelieve ons te contacteren indien enige assistentie of verdere informatie gewenst is Met dank en achting H Baartmans M Sc Director European Operations Verathon Medical Europe B V Ch o Comm 30127415 V A T number NL 80 37 37 750 B 01 Linnaeusweg 11 3401 MS IJsselstein The Netherlands US Dollars IBAN NL88ABNAO 58 43 75 670 Euro IBAN NL66ABNAO 58 43 75 581 Tel 31 0 30 68 70 570 Fax 31 0 30 68 70 512 BIC ABNANL2A Bank ABN AMRO IJsselstein E mail salesEUGverathon com Internet www verathon eu Inventors of AortaScan BladderScan VMode ScanPoint and GlideScope www verathon eu Goper Surgical 95 Corporate Drive Trumbull CT 06611 203 601 5200 31 oktober 2012 FAX 203 601 4741 Terugroepingsbericht DRINGEND AAN Klanten van de boogvormige baarmoedermanipulatie instrumenten van CooperSurgical BETREFT Voorzichtigheid van CooperSurgical UMH700 en vroege versies van de UMH750 handgrepen voor baarmoedermanipulatie Beste gewaardeerde internationale klant
100. int Handling Unit Director Quality EMEA Cc SYNTHES Page 3 of 3 NOTICE MEDICAL DEVICE RECALL Mandible Distractor multiaxial Verification Section Part Number Part Description Lot Number 487 931 Distractor Body Titanium Alloy TAV 7895264 7793390 7583381 7583380 7528840 3708643 3683421 3683403 3560888 487 966 Mandible Distractor multiaxial right 7765627 Titanium Alloy TAV 7562081 7532790 3800757 3757207 487 967 Mandible Distractor multiaxial left 7834374 Titanium Alloy TAV 7662788 7562083 3757213 3739743 _ We have located the identified product in stock returned quantity is documented below and have retained a copy of this letter for our records _ We do not have any identified product in stock returned quantity is zero and have retained a copy of this letter for our records RETURNED DEVICES including quantity Name Title please print Phone Number Signature and Date TELEFLEX MEDICAL EUROPE LTD HEESTERVELDWEG 11 3700 TONGEREN BELGIUM To the attention of Ulivieri Marco and Whiriskey Crowe Una Ivry le Temple October 9 2012 Registered Mail Urgent Field Safety Notice regarding a Medical Device the device Reference item 3008ECHO Batch Number 12081141 C009726 Kind of Action FIELD SAFETY NOTICE Dear Sir dear Madam Detailed information of the devices concerned PEROUSE MEDICAL has issued a Voluntary Field Safety Corrective Action r
101. ired for navigation with the Brainlab Cranial Navigation System 2 When sterilizing the Ultrasound Adapter according to the instructions in the Brainlab Cleaning Disinfection and Sterilization Guide the Adapter Latch see Figure 1 may become slightly deformed This may prevent a rigid fixation to the Ultrasound Probe Due to this issue an unnoticed movement between the Ultrasound Adapter including the attached Tracking Array and the Ultrasound Probe may occur during surgery This effect could cause a shift of several millimeters of displayed ultrasound information compared with the pre operative image sets displayed in the Navigation System If this potential shift is not detected by the user this could lead to ineffective treatment serious injury or even death of the patient No injury or ineffective treatment of a patient has been reported to Brainlab regarding this effect b c Adapter Latch Figure 1 Ultrasound Adapter BK Medical 8862 8863 FORM 14 04 CAPA 20121129 000146 Rev 7 Page 1 of 3 A BRAINLAB Details Navigated ultrasound is typically used to e Intraoperatively identify anatomical structures including their dislocation caused by brain shift e Visualize and mark anatomical structures e g tumor tissue or vessels This is done by comparing the intraoperative ultrasound image sets with the pre operative image sets in the Brainlab Navigation System To enable a relation of these data sets an www b
102. kken producten uit uw inventaris te verwijderen van de afdeling endoscopie centrale dienst goederenontvangst en verzending en eventuele andere relevante locaties Bewaar de producten afzonderlijk op een veilige plaats alvorens ze naar Boston Scientific terug te sturen U wordt verzocht het bijgesloten verificatieformulier in te vullen zelfs als u geen producten hebt die u wilt retourneren Nadat u het verificatieformulier ingevuld heeft kunt u het op of v r xx april 2012 naar uw plaatselijke Boston Scientific klantenservice faxen ter attentie van Customer Service Fax Number Als u producten heeft die geretourneerd moeten worden wordt u verzocht ze in een correcte verzendingsdoos te verpakken en Customer Service Tel uw plaatselijke Boston Scientific klantenservice te bellen om de retournering te regelen Breng alle gezondheidsdeskundigen in uw organisatie van dit bericht op de hoogte als zij dit moeten weten evenals alle instellingen waar de mogelijk betrokken producten aan zijn doorgegeven indien van toepassing Geef aan Boston Scientific de gegevens door van eventueel betrokken producten die aan andere organisaties zijn doorgeleverd indien van toepassing De bevoegde overheidsinstantie is van deze Kennisgeving inzake veiligheid op de hoogte gebracht We betreuren het ongemak dat deze actie voor u veroorzaakt maar stellen uw begrip voor onze maatregelen voor pati ntveiligheid en klantentevredenheid op prijs Als u vr
103. lthcare Sector Management Hermann Requardt 91052 Erlangen Imaging amp Therapy Division Systems Management Bernd Montag Germany Magnetic Resonance Management Bernd Ohnesorge Siemens Aktiengesellschaft Chairman of the Supervisory Board Gerhard Cromme Managing Board Peter Loescher Chairman President and Chief Executive Officer Roland Busch Brigitte Ederer Klaus Helmrich Joe Kaeser Barbara Kux Hermann Requardt Siegfried Russwurm Peter Y Solmssen Michael Suess Registered offices Berlin and Munich Germany Commercial registries Berlin Charlottenburg HRB 12300 Munich HRB 6684 WEEE Reg No DE 23591322 SCF 04 2011 V08 12 Page 1 of 2 SI EM ENS Letter of 5 Sept 2012 To all users of Siemens Flex Large 4 Coil for MAGNETOM Skyra Verio Spectra and Biograph mMR How to avoid any risk Siemens asks you to position the Flex Large 4 Coil only isocentric in head foot direction by using the laser light for careful positioning The maximum deviation should not exceed 5 cm in head foot direction This also implies that the coil must not be used for scanning with table movement You can freely position the coil with regard to any other position and direction Example for correct positioning in iso center Please include this safety information in the Operator Manual Coils and keep all operating personnel informed Thank you for your understanding and cooperation in following these instructions With best reg
104. mation weiter und informieren Sie die unten angegebene Kontaktperson Bitte bewahren Sie diese Information zumindest solange auf bis die MaBnahme abgeschlossen wurde Das Bundesinstitut f r Arzneimittel und Medizinprodukte hat eine Kopie dieser Mitteilung erhalten Kontaktperson Als Endkunde wenden Sie sich zur Abwicklung des Austauschs bitte an den Ansprechpartner Ihres H ndlers oder Distributors Sind Sie Fachh ndler oder Distributor wenden Sie sich zur Abwicklung Ihrer R cksendung bitte w hrend der blichen Gesch ftszeiten an Ihren Ansprechpartner im Customer Service Weitere Informationen zum Ablauf finden Sie auf der folgenden Seite Bei dar ber hinausgehenden Fragen wenden Sie sich bitte an Carola Janisch Manager Customer Service Telefon 49 8152 38 0 Fax 49 8152 38 202 Email info heine com Wir m chten an dieser Stelle betonen dass wir diese Situation sehr bedauern und uns bei Ihnen f r allen Aufwand und Unannehmlichkeiten die hiermit verbunden sind entschuldigen Gleichzeitig bedanken wir uns vielmals f r Ihre Hilfe und Unterst tzung Mit freundlichen Gr en HEINE Optotechnik GmbH amp Co KG fuf Georg Grohs Bereichsleiter Qualit tswesen Interne ID 15 2012 02 15 DE FSN HEINE HEINE Optotechnik GmbH amp Co KG Kientalstr 7 82211 Herrsching Germany Tel 49 0 8152 38 0 Fax 49 0 8152 38 202 E Mail info heine com www heine com May 2012 Urgent Field Safety Notice FSN
105. municatie OK S OK Stop Communicatie PW OFF Netspanning UIT TEL RX vanaf TEL NG overige fout Cont Doorgaan No Ans Geen antwoord Refuse Ontvangst geueigerd Busy Bezet M Full Geheugen vol LOVR Lengte ontvangst te lang FIL Bestandsfout DC Decodeerfout MDN MDN Respons fout DSN DSN Respons fout B BRAUN B BRAUN MEDICAL N V S A Woluwelaan 140 b B 1831 DIEGEM TEL FAX FAX RA TVR cvg 24 01 201 1 Diegem 24 januari 201 1 Recall Redon Drainage TUBE SOCM CH 10 Als 100 Europees familiebedrijf streeft B Braun Medical N V er steeds naar orn kwaliteitsproducten ter beschikking te stellen van het ziekenhuis is de pati ntveiligheid en uw tevredenheid onze belangrijkste bekommernis In dit kader wensen wij u op de hoogte te brengen van een recall voor het product Redon Drainage TUBE SOCM CH 10 Vanuit ons moederbedrijf werd ons melding gemaakt van een onvolledige lasnaad bij een single unit verpakking van de Redon drain Dit kan inviced hebben op de steriliteit van het betreffende product We kunnen niet uitsluiten dat andere producten uit dit lot hetzelfde defect vertonen Daarom vragen wij u om dit lot niet meer te gebruiken Om mogelijke problemen te vermijden heeft B Braun Medical N V beslist om dit lotnummer terug te halen uit de markt Het betreft de terugroeping voor Artikelnummer 123111000 Om de recallprocedure vlot te laten verlopen vragen wij uw medewerking Lotnummer 9K 1
106. n te worden De cli nten kunnen de huidige producten van de nieuw geleverde producten onderscheiden aan de hand van het lotnummer e Het huidige product heeft een lotnummer van zes 6 tekens bijvoorbeeld 123456 e De nieuw geleverde producten hebben een partijnummer van acht 8 tekens bij voorbeeld 123456EE Hoogachtend Johnson amp Johnson Medical N V F M J Reijntjens Quality Manager Benelux HOYA CORPORATION DE NTAX PENTAX Life Care Division Medical Instrument SBU Quality Assurance Department Field Corrective Action IFU Addendum for proper use of endoscopic accessories with PENTAX EG 3870UTK Ultrasound Video Gastroscope April 27 2012 TO Customer address Attention Risk Manager Urgent Medical Device Field Corrective Action Dear Valued Customer Pentax has initiated a Field Corrective Action involving the revision of Instructions For Use to clarify the method for advancing an accessory in the Pentax Ultrasound Video Gastroscope EG 3870UTK Issue Recently PENTAX has been notified of a potential risk related to the use of the EG 3870UTK Ultrasound Video Gastroscope in combination with aspiration needles if the Instruction For Use is not followed carefully by the user Specifically if the user fails to properly position the elevator while advancing the aspiration needle through the endoscope then the needle can disengage from the elevator as shown on the picture below This could result in the needle not being
107. ner AED PR rec Garde Spacer COMPAT deva on gode term omen g VW ea ora Compon hevale dea Lio 5 EE vert Candy Son pm 0 Cierra kur deco no caat 5 Figure 1 Example of a representative product label providing 1 is the manufacturing date white production plant symbol and 2 the manufacturing site dark production plant symbol Although the identified issue has been corrected at Zimmer GmbH Winterthur for products manufactured after March 2010 Zimmer recommends as a general practice to always check the patient label by comparing its information to the product label at the time of the surgery please see figure 2 aas sen tap el 02 00 07 013 Lor 2492002 y EUN pe Fee LI E a GEND n j a STERIL IEN n we 1 al din wi Zi eum e RIGHI Figure 2 Example of the product label left and patient label right Zimmer GmbH Winterthur has checked remaining inventories of the concerned products on stock at Zimmer Therefore future product deliveries from Zimmer from these products should no longer contain any discrepancies Action to be taken Our records indicate that your hospital currently has products from affected lots in its consignment inventories Therefore we kindly request that you read this letter and make sure personnel involved in surgery and patient file administration are informed accordingly Page 2 of 3 Zimmer GmbH Bo
108. niversel et les num ros de lot Veuillez noter que seuls les produits r pertori s dans le tableau ci apr s sont affect s Aucun autre produit Boston Scientific n est concern par cette notification d incident Mat riel UPN Mat riel UPN Catalogue r f Catalogue r f emballage emballage externe interne Aiguille droite emballage 14386589 14435130 14578709 14629530 14715963 SoloistTM 18cm M001262500 un Nom du dispositif de Lot Batch interne r f renc s emballage externe ci dessous 14722621 14776399 14805361 emballage 14383536 14432173 14581820 14625649 14715972 Soloist Electrode NS p Pero externe r f renc M001262510 ci dessus 14722622 14775117 14805368 Aiguille droite emballage 14383537 14434176 14581821 14625651 14715971 Soloist M 18cm externe reference M001262520 emballage interne ci dessus 14722623 14775116 14805362 Page 1 of 2 Sold_to CP INSTRUCTIONS 1 Veuillez imm diatement ne pas utiliser le produit Boston Scientific indiqu ci dessus et retirer toutes les unit s concern es de votre stock qu elles se trouvent dans la salle de cath t risme interventionnel en Radiologie Radioscopie Bloc Op ratoire Stock Central Service d exp ditions r ceptions ou autres services concern s Isolez les unit s concern es en lieu s r pour renvoi Boston Scientific 2 Veuillez remplir le Formulaire de v rification ci joint m me si v
109. nstructions in the second situation described above Corrective action As soon as the new release of the software is available your Telemis Medical installation will be updated free of charge and you will be informed of the correction Rest assured that the development engineers of Telemis are making every possible effort to correct this problem as soon as possible This is our absolute priority If you have any question please contact our product support e Belgium Switzerland 00 32 10 48 00 18 e France 00 33 534 273 840 e Italy 00 39 011 739 00 91 Telemis confirms that the national authorities have been informed of this safety notice oincerely Jean Claude Spelte Customer Services Manager ics telemis com Telemis S a 8 Rue de Clairvaux B 1348 Louvain la Neuve Ref 50038347 Date FIELD SAFETY NOTICE Commercial name of the product Barrier Extremity Drape 230x315cm Type of action Return of the Device Attention Theatre Manager Distributor Details on affected devices Product Code Batch Number 60213 00 12167258 Description of the problem It has been identified that Extremity Drape products manufactured as batch 12167258 may have a defect on the primary packaging in the form of a cut mark This cut mark may have pieced through the packaging resulting in a compromise in sterility if used during a Surgical Procedure Actions to be taken by the user 1 Please identify and isolate all affected unused p
110. olcano s software These software errors will cause the display to be shifted to a different Field of View FOV which if encountered will differ from the angiography values In the discussion below we describe the potential errors the remote set of conditions that must be met for the errors to occur and how to recognize when the errors have occurred We also describe how to avoid the errors You should institute these error avoidance steps until the permanent software patch is installed Please note that the In Line Digital ILD measurements VH IVUS ChromaFlo and Fractional Flow Reserve FFR measurements are not affected by this display error However once the errors have occurred any images captured in a Video Loop or Still Frame cannot be corrected but they can be detected 1 DIGITALIVUS CATHETER ERROR A software display issue may occur if the user changes the normal default FOV to another setting in addition to a unique sequence of events occurring This may lead to the graticules FOV display to revert back to the default setting but does not affect the gray scale image quality It has been reported twice from the field and in each case was immediately detected by the user This issue can occur when the following IVUS catheters are used Digital IVUS Catheters Eagle Eye Gold Eagle Eye Platinum PV 014 for Japan only VIBE RX Vascular Imaging Balloon Catheter Conditions Ca Error Occur Very specific conditions in the
111. olysite expiry date 2012 07 instead of being 2017 07 i L SI 1 CEloaso Chambre cath ter implantable implantable Port Implantie barer injections fort Camara implantable Port impiantabile Cateter totalmente implant vel Implanteerbafe katheterpoort implanterhare adgangsporter Implanterbare iniektionssystemer Implantoitavat v yl katetrit Wszezepiaine porty Eupuredatueg puexcev s noawmr kaonc implante edilebyir port implantabilni port kat trem fas cos implanterbara port Camera ifplantabil cu cateter Be ltethet kapu UO imnnantyersca 34 POLYSITE Echo 3008 ECHO eto CS 9 STERILE Sg SILICONE CATHETER lines INTRA VENOUS ADULT MINI PORT Tn X e Der Le Lot 12071189 SN 0143102652 i ES AN id 5 FEN LEN 3 Ke p MEE Y Q ff x 2 Q 1 2x2 4 mm L 60 cm p e ud PER USE 10 ml 2 5 mm 23 cm 18G 7 cm MEDICAL Route du Manoir 60173 Ivry le Temple FRANCE amp CUGAT roi 4 1 T l 33 013 43 08 17 05 Fax 33 09 44 98 17 M mA i Y www perousemedital com m n p 1 H D 22G 0 7 mm 0 035 60 cm PEROUSE MEDICAL Instructions for the implementation of the Field Safety Notice Devices stored in your facility and in the hospitals and clinics Our records show that your facility is currently having devices from this batch concerned see list in ap
112. orden gestaakt Wij vragen onze cli nten om de betreffende producten te retourneren Als u producten gebruikt waarvan de houdbaarheidsperiode verlopen is kunt u mogelijk de juiste sterilisatiecondities niet controleren Te ondernemen actie Wij hebben uw hulp nodig om ervoor te zorgen dat alle betreffende producten worden gelokaliseerd en volgens de volgende instructies worden gehanteerd PER DIRECT VAN TOEPASSING Controleer de vervaldatum op de verpakkingen van STERRAD CYCLESURE 24 Biological Indicator BD zie afbeelding 1 en zoek in de lijst met de betrokken partijnummers in bijlage 1 de huidige vervaldatum op het etiket en de gewijzigde vervaldatum conversie de vervaldatum op het etiket min negen 9 maanden om de juiste vervaldatum vast te stellen Location Lot Number Expiration Date Als u STERRAD CYCLESUREO 24 Biological Indicators BI heeft waarvan de vervaldatum verlopen is dienen deze geretourneerd te worden volgens de richtlijnen voor het retourneren in de alinea s hieronder ASP raadt u dringend aan om de producten waarvan de vervaldatum nog niet verlopen is handmatig te voorzien van een etiket met de berekende nieuwe vervaldatum zodat uw voorraad op de juiste wijze ge tiketteerd is voor gebruik Zie de conversietabel in bijlage 1 Retourneren van producten 1 Controleer uw voorraad en retourneer alle ongebruikte STERRAD CYCLESURE 24 Biological Indicator BI producten waarvan de berekende nieuwe v
113. ote Telefiex Medical can provide either replacement product at no charge or credit your account when the product is returned Please indicate which you desire on the Recall Acknowledgement amp Stock Status Form Instructions for Distributors If you are a distributor communicate this recall notice to your customers who received product within the scope of this recall by providing a copy of this recall notification to them Also provide a copy of the Acknowledgement Form This form should be completed in its entirety signed and returned to you the Distributor As a Distributor it is your responsibility to provide Teleflex Medical with a certification that all of your consignees have been contacted under this recall If you have any other questions please feel free to contact your local sales representative or the Teleflex Medical Customer Service available at 01494 532761 Meleflex MEBICAL 5 Teleflex Medical Action Teleflex Medical is notifying any potentially affected Customers Teleflex Medical employees and Distributors of this Field Safety Notice 6 Transmission of this Field Safety Notice This notice should be passed on all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred 7T Contact reference person Should you require any further information or support concerning this issue please contact H l ne Sauvage Phone
114. our retourner les produits l Examinez votre stock et retournez tous les indicateurs biologiques IB STERRAD CYCLESURE 24 inutilis s qui ont d pass la nouvelle date de p remption d finie 2 Comptez physiquement votre stock de produits ayant d pass la nouvelle date de p remption d finie et consignez les donn es sur le Formulaire de r ponse 1 Remplissez le Formulaire de r ponse et retournez le fax 02 746 3001 dans un d lai de 3 jours ouvrables m me si vous ne poss dez pas les produits concern s Si vous avez des produits retourner conservez un exemplaire de ce formulaire pour vos dossiers 2 Pour retourner un produit concern joignez un exemplaire du Formulaire de r ponse au produit Votre repr sentant se tient votre disposition pour vous aider appliquer ce Rappel de produits volontaire l intention des utilisateurs si vous demandez une assistance Transmission de l avis de s curit D apr s notre base de donn es il a t d termin que vous avez recu l un des produits figurant en annexe 1 Partagez cette lettre avec tous les membres du personnel de votre tablissement qu elle concerne 51 vous avez des questions ou souhaitez un compl ment d informations sur ce bulletin vous pouvez contacter votre Product Specialist Nous vous pr sentons nos excuses pour les d sagr ments que cela pourra vous causer permettez nous de vous assurer que nous ferons tout ce qui est en notre pouvoir pour
115. ous n tes en possession d aucun des produits retourner 3 Veuillez envoyer le Formulaire de v rification d ment rempli par fax au Service clients local de Boston Scientific l attention de la Customer Service Fax Number au plus tard le xx mars 2012 4 Si vous avez des produits retourner veuillez les emballer dans une boite d exp dition appropri e et contacter Customer Service Tel de votre Service Clients Boston Scientific pour convenir des modalit s de retour 5 Nous vous remercions d informer les professionnels de la sant de votre tablissement utilisateurs de ces produits de ce retrait ainsi que tout tablissement o les produits concern s auraient pu tre envoy s Veuillez fournir Boston Scientific toutes informations utiles sur les produits concern s qui ont t envoy s d autres tablissements le cas ch ant L autorit comp tente de votre pays a t inform e de cette notification d information de s curit Nous regrettons les d sagr ments engendr s par cette mesure visant garantir la s curit des patients et la satisfaction de nos clients et vous remercions pour votre compr hension Pour toute information compl mentaire concernant cette notification d incident veuillez contacter votre repr sentant Boston Scientific Avec nos sinc res salutations Sandra Hassler Quality Department Boston Scientific International S A Pi ce jointe Formulaire de v rification
116. oviding you with the highest level of service product quality and reliability We appreciate your understanding and we regret any inconvenience that may cause you Please complete the attached reply form to acknowledge receipt of this FSN and return it via fax to the number on the form It is important to indicate the number of system operating manuals at your location on the reply form so we can send the correct number once completed Please forward this Field Safety Notice to all colleagues within your organization who need to be aware of it or to any organization where the potentially affected devices have been transferred Please maintain awareness of this notice until Hospira notifies you of completion Should you have any further questions please do not hesitate to contact your local Hospira office Hospira EMEA T 44 1926 834 400 To report adverse events Product Safety Email to or product complaints devicecomplaintsemea hospira com Hospira EMEA Quality T 31 36 5274 720 Additional information F 31 36 5274 701 and technical assistance Email to devicesfieldactions hospira com The Competent Authorities in all countries affected by this action have been informed of this field safety notice Yours sincerely AD Kee Wilson Kennedy EMEA Devices Quality Manager Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW United Kingdom Telephone 44 0 1926 820 820 Eoo o a www hospira com R
117. patient s lungs Figure 1 SHER I BRONCH Swivel Connector The tether is identified by the tag 1 in the image above 3 Advise on action to be taken by Medical Staff Our records indicate you have received product included in the scope of this recall We are notifying our Customers to take the following action MEDICAL RECALL INSTRUCTIONS instructions for Hospitals Medical Staff Customers 1 Check your stock for the products included within the scope of this recall Cease use and distribution and quarantine all affected product immediately 2 Contact Teleflex Medical Customer Service Department at 01494 532761 for a Return Authorization Number Once you have received the Return Authorization Number please enter it in the space provided on the attached Recall Acknowledgement amp Stock Status Form 3 Complete the enclosed Recall Acknowledgement amp Stock Status Form and immediately fax back to Teleflex Medical Fax number 01494 524650 Attn Customer Service This will allow us to document your receipt of this letter and ER the amount of product you have on hand for return 4 Return any affected product freight collect along with the original completed Recall Acknowledgement amp Stock Status Form to the following Helene Sauvage Stiring Road Cressex Business Park High Wycombe HP12 3ST England Phone 44 0011494 532761 Fax 44 071494 524650 E mail orders uk teleflexmedicai com N
118. pendix We ask you to immediately quarantine all the non distributed products It s the distributor s responsibility to inform the concerned hospitals or clinics on your domestic markets and to ask your customers to put in quarantine all the non used devices In order to avoid any confusion for the users we ask you to put a sticker which mentions the correct expiry date on each POLYSITE concerned We would be grateful to receiving from you the list with the serial numbers of the products not yet used and still in stock on your shelves or on your customers shelves see list enclosed Please send us back the list before October 12 2012 Upon reception of this list we will send you the required quantity of labels needed to re label the units stored in your facility and the units still in stock on your customers shelves Implanted devices Regarding the devices already implanted the incorrect labelling does not constitute any hazard for the patient as the effective expiry date is 3008ECHO JULY 2017 3017ECHO JUNE 2016 The traceability labels do not include the expiry date information It is the responsibility of the hospital clinic to check if this expiry date has been or not reported in the patient file If the expiry date is mentioned in the patient file we ask you to inform your customers to follow their facility s protocol for manually report the effective expiry date of the device Distribution of the Field Safety Not
119. rainlab com Ultrasound Adapter Base including an Ultrasound Tracking Array must be attached to the Ultrasound Probe This allows the navigation system to track the location of the Ultrasound Probe and its field of view throughout the procedure A rigid fixation between the Ultrasound Probe and adapter is essential for the accuracy of the Ultrasound information shown in the Brainlab Navigation System The Ultrasound Adapter BK Medical 8862 8863 is intended to be attached on the Ultrasound Probes BK Medical 8862 and 8863 However due to the design of the adapter there might be movement of several millimeters possible between adapter and probe despite that the adapter is correctly attached to the probe This effect may worsen when the Ultrasound Adapter BK Medical 8862 8863 is sterilized Despite that the adapter is intended to be steam sterilized the sterilization might have a negative effect on the Adapter Latch that is used to fixate the adapter on the probe refer to Figure 1 After sterilization the latch might be slightly deformed and therefore proper closing may no longer be possible If movement of the Ultrasound Adapter relative to the Ultrasound Probe would occur during a surgery this could lead to a shift of the intraoperative ultrasound image data compared to the pre operative image sets displayed in the Navigation System User Corrective Action According to our records you are the owner of the potentially affected article
120. recall by Smith amp Nephew Endoscopy for certain metal and peek suture anchors due to a packaging issue Specifically we have identified pin holes in a small number of pouches which constitutes a breach of the sterile barrier The affected suture anchors include many from the BIORAPTOR FOOTPRINT HEALICOIL and TWINFIX product lines A full list of affected product is attached for your reference In the most likely scenario a patient would have no adverse reaction to a device with a pin hole in the package however it is possible that during a surgical procedure a fixation device is prepared for the procedure but the physician or prep nurse will overlook a pin hole in the pouch before placing the device into the sterile field The non sterile device will then be used during a routine surgical procedure and may result in an adverse reaction surgical site infection that is reversible with aftercare by the physician In rare instances there exists the remote possibility that the patient may experience a systemic infection sepsis resulting in organ failure and death Our records show that this item has been despatched to you recently If you have any of these devices please remove isolate the items and contact Product Services on 01480 423200 select option 2 who will arrange for the item to be collected and replaced Please complete the declaration on the following page by inserting the number of items held and return the form as outlined
121. rhandeld en naar wie 1 de eenheid is verkocht specificeer de datum dat de eenheid werd verkocht en aan wie overig specificeer de datum en wat er met de eenheid gebeurd is PERSOON DIE DE VRAGENLIJST INVULT Naam Titel Telefoonnummer Bedrijfsnaam Adres Plaats Staat FAX HET INGEVULDE FORMULIER NAAR FAX 1 93 526 448 BETREFT M11 Sterilizer FCA OF SCAN HET INGEVULDE ANTWOORDFORMULIER EN E MAIL HET NAAR fieldcorrection midmark com HEINE HEINE Optotechnik GmbH amp Co KG Kientalstr 7 82211 Herrsching Germany Tel 49 0 8152 38 0 Fax 49 0 8152 38 202 E Mail info heine com www heine com Mai 2012 Dringende Sicherheitsinformation FSN Sicherheitsrelevante korrektive MaBnahme im Feld FSCA betrifft LED Batterieeinschub f r HEINE Standard F O Laryngoskopgriff mit LED Beleuchtung An Medizintechnische Fachh ndler Verantwortliche f r Medizintechnik Krankenhausverwaltung Abteilung Medizintechnik Abteilung An sthesie Identifikation der betroffenen Medizinprodukte LED Batterieeinschub ohne Bodeneinheit HEINE Katalog Nummer REF F 008 22 890 DT SN 1230009124 Seriennummer HEINE LED Laryngoskop Batterieeinschub Von dieser korrektiven Ma nahme betroffen sind alle LED Batterieeinsch be mit den Seriennummern 1230000000 bis 1230999999 Die betroffenen Ger te wurden im Zeitraum vom 12 02 2010 bis 15 09 2011 hergestellt Von dieser MaBnahme nicht bet
122. riffe Ein Ausfall der Beleuchtung k nnte dazu f hren dass eine Intubation nur verz gert oder gar nicht durchgef hrt werden kann wenn alternative Ger te oder Mittel zur Atemwegssicherung nicht oder nicht rechtzeitig zur Verf gung stehen Die betroffenen Batterieeinsch be k nnen in seltenen F llen Kontaktprobleme aufweisen wenn sie mit Prim rzellen Batterien bestimmter Hersteller betrieben werden Als Ursache der Ausf lle wurde ein unterbrechungsanf lliger Kontakt des LED Batterieeinschubs zu dem Pluspol der Batterien identifiziert Dies wurde beobachtet wenn die Batterien z B nach einem Sturz des Laryngoskops stark gestaucht waren oder der Pluspol der Batterie mechanisch nicht zum Kontakt des LED Batterieeinschub passte Bislang konnten wir dieses Verhalten beim Einsatz von Batterien des Typs VARTA HIGH ENERGY No 4914 oder bei Verwendung von gestauchten Batterien erkennen och digungen von Patienten wurden uns bisher nicht berichtet Wir haben uns dennoch zu dieser freiwilligen Ma nahme entschieden da f r uns die Sicherheit Ihrer Patienten an erster Stelle steht Welche Ma nahmen sind durch den Empf nger dieser Mitteilung zu ergreifen 1 Bitte berpr fen Sie anhand der Seriennummer des LED Batterieeinschubs ob Sie betroffene Produkte in Ihrem Bestand haben 2 Befinden sich in Ihrem Bestand betroffene Produkte pr fen Sie als n chstes ob die Ger te mit Trockenbatterien oder HEINE Ladebatterien betrieben werden
123. rlopen vragen wij uw medewerking Gelieve ons de aantallen van de betrokken referentie mee te delen via bijgevoegd antwoordformulier Van zodra wij uw formulier hebben ontvangen wordt verwittigd wanneer we de goederen komen ophalen De ingeleverde goederen worden vervangen door een nieuw lot TEL 32 0 70 22 33 00 info be bbraun com RPR Brussel RPM Bruxelles FAX 32 0 70 22 33 88 order be bbraun com BTW TVA BE 0407 089 994 B BRAUN Mogen wij u eveneens vragen de loten reeds aanwezig in het operatiekwartier te verifi ren en indien nodig terug te nemen We blijven steeds tot uw beschikking voor verdere informatie specifieke productvragen gt Product Specialist Christel Van Goidsenhoven GSM 0478 72 94 50 logistieke vragen gt Patricia Coeckelbergh rechtstreeks nummer 02 712 86 59 Wij danken u in het bijzonder voor de aandacht die u geeft aan dit schrijven en voor het gestelde vertrouwen in ons bedrijf Hoogachtend B Braun Medical N V S A JH Trees Vanryckeghem Marc Tielens Regulatory Affairs Manager Managing Director Bijlage Antwoordformulier TEL 32 0 70 22 33 00 info be bbraun com RPR Brussel RPM Bruxelles FAX 32 0 70 22 33 88 order be bbraun com BTW TVA BE 0407 089 994 Antwoordformulier Gelieve dit antwoordformulier terug te faxen naar Patricia Coeckelbergh 070 22 33 88 zelfs indien u geen voorraad heeft Recall Redon Drainage TUBE 50CM CH 10 U2111000 LOT
124. roblem happens only when using fusion on nuclear medicine images No incident has been reported to this date This problem could affect patient security Please ensure all potential users of your institution have read this security notice and the security recommendations Impacted systems The problem happens in all 4 30 releases of the Telemis Medical image viewing software Problem description SUV measurements are incorrect on fusioned images displayed in MPR mode All measurements are incorrect on fusioned images which have been reconstructed These problems can lead to a wrong interpretation of images Situations in which the problem occurs The problems happen when the user selects two series in the browser and displays them using the fusion mode 1 If the user opens the series in fusion mode directly from the browser in any 2D or MPR mode and then measures a SUV in this viewer the SUV measurement is correct If from a 2D or a classic MPR viewer the user opens a new MPH viewer of any type except classic MPR the SUV measurement in the new viewer is incorrect 2 If the user generates a reconstruction from a MPR viewer of any type except classic MPR displaying fusioned images all measures of any type on the reconstructed images are incorrect Security recommendations To avoid these problems please 1 Refrain from using the SUV measurement tool in the first situation described above 2 Refrain from generating reco
125. roduct at your facility 2 Please complete the attached Confirmation form fax back per its instructions This step is required to confirm receipt of communications with all customers 3 Return the attached response form even if no recalled product is in inventory 4 f you have forwarded any affected product to any other healthcare institutions please forward a copy of this letter and fax back containing affected serial numbers to those institutions 5 M lnlycke Health Care will arrange for collection and replacement of the product from your facility Please contact your local Molnlycke Health Care Customer Service or Account Manager if you have any questions or concerns regarding this notification You may also contact Vigilance Caroline Price vigilance molnlycke com or 44 0 161 777 2646 Molnlycke Health Care also confirms that this notice has been notified to the appropriate Regulatory Agency Please be assured that maintaining a high level of safety and quality is our highest priority If you have any questions please contact us immediately Sincerely P Caroline Price Steven Dowdley Vigilance Associate Global Director of Regulatory Affairs Page 1 of 2 Field Safety Notice Ref 50038347 PLEASE COMPLETE AND RETURN THIS FORM TO Caroline Price Vigilance Associate M lnlycke Health Care 2 Omega Drive Irlam Manchester M44 5BJ Tel 44 0 161 777 2679 Fax 44 0 161 621 2045 E mail vigilance molnlycke com
126. roffen sind die LED Batterieeinsch be deren Seriennummer mit 1231 oder 1232 beginnt Bitte beachten Sie dass die LED Batterieeinsch be sowohl als Einzelteil als auch als Bestandteil der folgenden Artikel ausgeliefert wurden Artikelbezeichnung CURE Artikelbezeichnung STAND F O LED LARYN GR 2 5V F 008 22 860 FLEXTIP LED LARYNGOSK SET FT3 F 227 28 865 Katalog Nummer STAND F O LED LARYN GR 3 5V F 008 22 863 F O LARYNG SET MAC MODULAR F 228 18 860 LED BATT EINSCHUB F STAND F O F 008 22 890 F O LARYNG SET MAC MODULAR F 228 28 865 HRA 52 039 M nchen Heine Optotechnik Verwaltungs GmbH Herrsching HRB 45192 M nchen Gesch ftsf hrer Dipl Kfm Helmut M Heine Oliver Heine BA WEEE Reg Nr DE 87119271 Interne ID 15 2012 02 15 DE FSN HEINE Artikelbezeichnung E dd Artikelbezeichnung BER mus LARYN LADEGR STAND F O LLED F 008 22 891 FLEXTIP LED LARY SET FT3 FT4 F 230 18 860 F O LED LARYN SET F 119 F 119 18 860 FLEXTIP LED LARY SET FT3 FT4 F 230 28 865 GR FO LED LARYNG SET F 120 F 120 18 860 DEMO SET UPGRADE LARYNGOSCOPES F 261 20 820 F O LED LARYN SET F 119 F 119 28 865 FLEXTIP LED LARY SET FT3 FT4 F 230 28 865 GR FO LED LARYNG SET F 120 F 120 28 865 MO Beschreibung des Problems einschlie lich der ermittelten Ursache Wir erhielten sehr vereinzelt Berichte von Anwendern ber Ausf lle der oben angegebenen LED Batterieeinsch be f r die HEINE Standard F O Laryngoskopg
127. ructions detailed on the attached addendum the instructions included in the addendum are translated for the purpose of this field action and final translation will be available upon release of the updated Instructions for Use In addition enclosed with this letter is the field correction response form Please forward this letter along with the addendum to the Instructions For Use for the EG 3870UTK Ultrasound Video Gastroscope and the field correction response form to the User Department s in your facility so they can review the information provided and complete the response form Please be assured that maintaining a high level of safety and quality is our highest priority If you have any questions please contact us immediately Contact Information According to the local responsibility oincerely Wijnand Stijn General Manager PENTAX Europe GmbH Quality Assurance and Regulatory Affairs EMEA 2 2 Telemis s a 8 Rue de Clairvaux lelem IS B 1348 Louvain la Neuve URGENT FIELD SAFETY CORRECTIVE ACTION Telemis Medical Software Reference FSCA 12109 Date July 9th 2012 Recipients of this document This document is intended for all users of the Telemis Medical software and in priority to the chief of radiology to the PACS Manager and the IT Manager Subject Telemis recently discovered a security problem regarding measurements taken on fusioned images using the image viewing software of Telemis Medical The p
128. s and to provide any required support We regret that this has occurred and any inconvenience it may cause or has caused you your patients or your staff If you have any questions please feel free to contact us under phone number 41 62 832 07 43 or by e mail european complaint smith nephew com Contact Details of Subsidiary Distributor Return Slip Please complete and return this feedback information to the contact specified above to prevent repetitive enquiries We confirm the receipt of this Field Safety Notice Institution Reference R1109 Name Date Signature Page 2 2 Sold_to CP Hospital Name Users Name Department Customer Address Zip Code City Country name Betreft 90748268 FA xx maart 2012 Kennisgeving veiligheid Dringende terugroeping van medisch product Soloist Single Needle Electrode Geachte Users Name Boston Scientific start een terugroeping van medische instrumenten m b t de Soloist Single Needle Electrode Door intern onderzoek hebben wij opgemerkt dat de Soloist Single Needle Electrode ge tiketteerd is met incorrecte uiterste gebruiksdata De uiterste gebruiksperiode op het etiket van de elektrode 20 jaar en de buitenste verpakking 5 jaar is langer dan de acceptabele uiterste gebruiksperiode van drie jaar Naar verwachting zal er geen letsel optreden als gevolg van deze kwestie met de etikettering omdat alle producten met d
129. s likely to occur For example the size E zimmer standard CR femoral component overhangs the purple Tibial 1 2 micro articular surfaces by 7 mm 0 276 on each side of the polyethylene The femoral component overhangs the striped yellow Tibial 3 4 articular surfaces by 3 mm 116 per side The size C standard CR femoral component only overhangs the purple micro articular surfaces by 3 mm 118 per side and does not overhang the striped yellow articular surfaces Thus edge loading with a size C femoral and striped yellow articular surface 1s unlikely to occur See Appendix 1 In general patients receiving a size 1 or 2 tibial plate are lighter in weight and thus would be expected to place lower loads on the implant lessening the risk of increased wear or fracture This may minimize the potential complications due to loading at the edge of the tibial polyethylene surface in this patient group Frequently Asked Questions What should I tell my patients e tis at the surgeon s discretion whether a patient should be called back to the clinic for examination and radiographic review to determine if there 1s any related problem If the surgeon decides to call back a patient the patient can be informed of the potential complications and advised of the need for annual physical examination and radiographs Do patients already implanted with an incompatible component combination require revision e tis at the discretion of the
130. sen R ckruf verursacht werden Setzen Sie sich mit uns in Verbindung wenn Sie Hilfe oder weitere Informationen ben tigen Vielen Dank x Verathon Medical Deutschland Henri Baartmans M Sc Siegener StraBe 32 D 56477 Rennerod Director European Operations les 2 is 911 284 Fax 49 0 2664 911 285 Verathon Medical Europe B V nfo de verathon de www verathon eu Verathon Medical Deutschland Siegener Stra e 32 D 56477 Rennerod CE Tel 49 0 2664 911 284 Fax 49 0 2664 911 285 E mail infode verathon de Internet www verathon eu Inventors of BladderScan VMode and ScanPoint www verathon eu N VERATHON MEDICAL URGENT Avis de s curit BE Vid o Laryngoscopes GlideScope 30 octobre 2012 Rappel Retour de dispositif m dical Cher client du GlideScope Verathon fabricant des vid o laryngoscopes GlideScope organise un rappel volontaire de certains lots de lames de vid o laryngoscopes r utilisables pr sentant un risque potentiel de fissuration Ces lames de vid o laryngoscopes produites entre d cembre 2010 et ao t 2011 sont compatibles seulement avec le moniteur analogique GlideScope GVL 0570 0200 0231 0003 Les lots concern s par cette action de rappel sont GlideScope GVL 3 r f n de s rie 0574 0007 MD105000 MD112387 GlideScope GVL 4 r f n de s rie 0547 0001 LG105000 LG112758 GlideScope GVL 5 r f n de s rie 0574 0030 XL105000 to XL111798 Le probl me as
131. soci au produit concern est un risque de fissure sous contrainte de l extr mit de la lame qui pourrait ne pas tre facilement d tectable lors de l inspection de routine pr c dant l intubation Cette fissuration peut entrainer un chec du dispositif A ce jour aucune blessure de patient li e ce probl me n a t report e Verathon La r vision du design et des proc d s de fabrication mis en place en ao t 2011 ont limin ce probl me Nous avons modifi le design de la lame du laryngoscope pour pr venir le pire sc nario dans lequel des pressions entre deux parties jointes de la lame entrainait parfois une forte tension interne qui auraient pu voluer en fissures Pour limiter l interruption de la disponibilit de votre syst me GlideScope Verathon va remplacer gratuitement votre lame de vid o laryngoscope par un nouveau dispositif Les unit s de remplacement seront garanties un an Pour toute question propos de ce rappel contactez votre repr sentant Verathon directement chez notre service client Verathon au 31306870570 Les autorit s l gales concern es sont inform es de la conduite de ce rappel S il vous plait communiquez tout disfonctionnement soup onn ou v nement ind sirable li s aux dispositifs GlideScope concern s au service client de Verathon ou aux autorit s appropri es Merci pour votre attention imm diate ce sujet Verathon s engage fournir des produits de la plus haute q
132. ssement s il y a des modalit s qui g n rent des images avec une profondeur de pixel sup rieure 12 bits Les fonctions mentionn es ci dessus ne peuvent tre utilis es pour les images de ces modalit s jusqu ce que le logiciel rem diant ce dysfonctionnement soit install sur votre syst me Siemens Group Belgium Luxembourg Adresse de correspondance T l 32 0 2 536 21 11 Healthcare Sector Management Luc Van Overstraeten Square Marie Curie 30 Fax 32 0 2 536 24 92 Customer Service Division Management Stefaan De Moor 1070 Bruxelles www siemens be Siege social Siemens SA Square Marie Curie 30 1070 Bruxelles Belgique BTW TVA BE 0404 284 716 RPR Brussel RPM Bruxelles BNP Paribas Fortis 210 0040988 09 Deutsche Bank 826 0004664 25 Erkenningsnummers Num ros d agr ment Beveiligingsonderneming Entreprise de s curit 20 1321 06 EORI nummer Num ro EORI BE04 Pagei de 2 SIEM ENS Lettre du 10 ao t 2012 H IM RR mw P1124 Comment ce probl me sera t il r solu La version de logiciel VA70B 0113 pour syngo Imaging XS rem diera ce probl me Celle ci sera disponible dans le courant du premier trimestre 2013 Notre ing nieur de service vous contactera afin de planifier l update Nous vous prions de transf rer imm diatement cette information votre personnel et de joindre le pr sent courrier au manuel d utilisation de votre systeme afin que les utilisateurs en tiennent compte jusqu ce que l update s
133. stcode Plaats Diegem 6 juli 2012 Ref FMJR 12 193 VEILIGHEIDSBULLETIN CycleSure 24 Biological Indicator Geachte heer mevrouw Product Het probleem betreft de volgende productcodes en partijnummers REF 1414324 STERRAD CycleSure 24 Biological Indicator REF14325 STERRAD CYCLESURE 24 Test Pack REF 20239 STERRAD NX Test Pack REF 20243 STERRAD 100NX International Test Pack REF 20123 STERRAD 100NX EXPRESS Cycle Test Pack REF 20232 STERRAD 50 1005 Sterilizer CYCLESURE 24 Validation Kit REF 20233 STERRAD 200 Sterilizer CYCLESURE 24 Validation Kit REF 20253 STERRAD NX Validation Kit REF 20228 STERRAD 100NX Validation Kit REF 20248 STERRAD 100NX EXPRESS Cycle Validation Kit Zie bijlage 1 voor de betreffende lotnummers Probleem De vervaldatum komt mogelijk niet overeen met de gegevens in de ASP documentatie Advanced Sterilization Products ASP heeft onlangs vastgesteld dat er onvoldoende gegevens zijn om de producten over de gehele op het etiket vermelde houdbaarheidsperiode te kunnen garanderen Daarom verzoekt ASP de cli nten om hun voorraad STERRAD CYCLESURE 24 Biological Indicator BI op te nemen en de houdbaarheid van al deze producten te vergelijken met de gewijzigde houdbaarheidsperiode volgens de instructies in de alinea MAATREGEL hieronder Het gebruik van producten uit partijen STERRAD CYCLESURE 24 Biological Indicators BIs waarvan de nieuw vastgestelde houdbaarheidsperiode verlopen is dient direct te w
134. stograms is niet correct voor beelden met een pixeldiepte boven de 12 bits Gelieve er rekening mee te houden dat bovengenoemde waarden in vroeger gegenereerde beelden ook niet juist zijn Alle waarden berekend voor beelden met een pixeldiepte kleiner dan of gelijk aan 12 bits zijn echter wel correct Hoe kan dit probleem vermeden worden Gelieve te checken of er in uw instelling modaliteiten zijn die beelden met een pixeldiepte boven de 12 bits genereren Bovengenoemde functies mogen niet voor beelden van deze modaliteiten gebruikt worden totdat de software die dit probleem verhelpt geinstalleerd is op uw systeem Hoe zal dit probleem verholpen worden Dit probleem zal verholpen worden door de softwareversie syngo plaza VA20D HF01 Deze zal in de loop van het derde kwartaal van dit jaar beschikbaar zijn Onze service ingenieur zal contact met u opnemen om de update te plannen Siemens Group Belgium Luxembourg Tel 32 0 2 536 21 11 Healthcare Sector Management Luc Van Overstraeten Fax 32 0 2 536 24 92 Customer Service Division Management Stefaan De Moor www siemens be Maatschappelijke zetel Siemens nv Marie Curiesquare 30 1070 Brussel Belgi BTW TVA BE 0404 284 716 RPR Brussel RPM Bruxelles BNP Paribas Fortis 210 0040988 09 Deutsche Bank 826 0004664 25 Erkenningsnummers Num ros d agr ment Beveiligingsonderneming Entreprise de s curit 20 1321 06 EORI nummer Num ro EORI BE04 Blz 1 van 2 C E n N N
135. surgeon regarding any patient care Zimmer recommends that the surgeon continue with their normal post operative follow up and monitor the patient especially if they present with pain more than three months after the surgery took place Zimmer does not want to unnecessarily alarm patients especially if they have a perfectly functioning implant and are not experiencing pain Again it is important to note that there have been no reported long term failures due to the incompatible combination of standard and micro components Is there information available to me or my patients from Zimmer A call support team is ready and equipped to handle your call the contact number is national Why are you emphasizing the use of the Compatibility Chart e Zimmer received reports describing the use of incompatible combinations of its NexGen Cruciate Retaining CR Micro Articular Surface components Because of these incidents we want to answer any questions and prevent any possible future occurrences Is the current labeling correct e Yes the compatibility chart and package labeling reflects the approved combinations of available femoral components tibial components and poly articular surfaces for the NexGen CR implant system zimmer Your Responsibilities 1 Review the attached Compatibility Chart and familiarize yourself with the appropriate component combinations 2 Complete the acknowledgement certification and return to national procedure
136. ter provides important safety information regarding Medtronic s Enterra Therapy System Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and or perforation Nature of the Issue Medtronic has received 15 reports since November 2002 of bowel obstruction and or perforation of the bowel associated with Enterra Therapy system leads Based on these reports the estimated incidence of these events combined is 0 4 of the total Enterra system implants worldwide Of the 15 reported events 4 did not provide information regarding patient outcome and the remaining 11 events all required surgical intervention There were 7 reports of necrosis 1 of which also included infection In the 11 cases that reported a patient outcome all 11 patients recovered without sequela No death has been reported to be associated with this field notification Scope This issue is related to the Enterra Therapy system and is not specific to a particular model number lot number or serial number Potential Severity of the Issue If a patient experiences bowel obstruction or perforation it may lead to life threatening intra abdominal infections and may require laparotomy bowel resection and or system revision Medtronic is updating Enterra Therapy system labeling to include the following warnings regarding bowel obstruction perforation Technical Manuals Bowel obstruction pertoration
137. u identifier comme origine de cette d faillance un contact ayant tendance s interrompre entre le boitier piles LED et le p le positif des piles Ceci a t observ lorsque les batteries apr s une chute par exemple du laryngoscope ont t fortement entrechoqu es ou que le p le positif de la pile n entrait plus en contact m canique avec le boitier piles LED Jusqu pr sent nous avons pu constater ce ph nom ne avec des piles du type VARTA HIGH ENERGY No 4914 ou en utilisant des piles ayant subi des chocs Des dommages corporels sur des patients ne nous ont ce jour pas t rapport s Nous avons n anmoins d cid de prendre volontairement cette mesure car la s curit des patients est notre priorit Quelles mesures doivent tre prises par le destinataire de cette communication 1 Veuillez v rifier l aide du num ro de s rie du boitier piles LED si vous tes en possession des produits concern s 2 Si vous poss dez effectivement ces produits veuillez ensuite v rifier si les appareils sont utilis s avec des piles s ches ou avec des piles rechargeables HEINE a Utilisation avec des piles s ches o Veuillez contacter votre revendeur ou fournisseur pour un change gratuit o Veuillez vous assurer que les boitiers piles LED concern s ne sont plus utilis s dans votre tablissement o S il ne vous est pas possible de cesser d utiliser le laryngoscope avec le boitier piles
138. u nu EN Ti ir AGE SH uouoJg pieus eqn 13 460080910 6802441 IX TLEOSTL LOGLYEL OLELEZL TESBLTIL 696S0ZL 89126L E 096981 E ESVESLL 6691 h48YS eqni 13 0900080W 0 04L0080HL0 BSOOOBOHLO 2220080110 BSEDOBOBLO GGLODLOMLO SSZOPZLX PPZO8ZL LBLFLEL GLEEEZL div ST u ucig ZOLZEZL 669872 021501 DALZGLL Fv2 6LL PECOGLL 07SS8LL BLISLLL 1202 11 2894914 29019010 ZOSPPLE 48U5 Sqn 13 0 006041 0 L800060 LO FF00060V LO 7OS0080M LO EOSOOBOALO EZEDOSONLO SZEOOBONLO 0450080910 86 00803L0 2620080110 00803 0 8900080010 LGE0080010 6 0090810 965 0080810 6100 0110 BSECOLOMLO 8S000 0ML0 SZLL8ZL BGBELEL 168ELZL ELLLLES LZ802ZL 0280221 600992 99889271 HLIGSZI OBLESEL vS9ovel QLZOVZL SPOGETL ELVBEEL HYOVET Lreszzl LGEOTTL EELSLT QVOSLTL 056 02 6099021 EEIEIE lea Snid amp AON dip S7 uouodg Heus eqn 83 _ 1900080410 09100703110 0265021 1414611 98 8 11 SOLLOLL siequnNjolpepeuv F AE j T LN t KITE XI JR SL NET AL LE LL EE GJL OO TE A A O A apon diz eyeys AD sseuppy sSqQUINN euoudeja L aunjeubis ALIEN 9 20 oni SUIeN Wud BA0GE USAJD soqunu 341 Je E91P9IN X9jJ9jo L 0 xe Ajejerpeuiru pue WO y JUSWD pa MOUYIV SIL 3ja duog ETA A E In PE MEER PE KR E fee d ELE All e mann piene ee
139. ualit et nous regrettons tout inconv nient g n r par ce rappel Nous vous encourageons nous contacter pour toute assistance ou information Verathon Medical Europe B V Ch o Comm 30127415 V A T number NL 80 37 37 750 B 01 Linnaeusweg 11 3401 MS IJsselstein The Netherlands US Dollars IBAN NL88ABNAO 58 43 75 670 Euro IBAN NL66ABNAO 58 43 75 581 Tel 31 0 30 68 70 570 Fax 31 0 30 68 70 512 BIC ABNANL2A Bank ABN AMRO IJsselstein E mail salesEUGverathon com Internet www verathon eu Inventors of AortaScan BladderScan VMode ScanPoint and GlideScope www verathon eu N VERATHON MEDICAL URGENT Field Safety Notice GlideScope Videolaryngoscopen November 2012 Recall Terugname van Medical Device Producten Ter attentie van Geachte GlideScope gebruiker Verathon producent van de GlideScope videolaryngoscopen voert een vrijwillige terugname uit van enige specifieke productiebatches van haar herbruikbare videolaryngoscoopbladen in verband met potentieel optredende breuk Het betreft hierbij de videolaryngoscoopbladen geproduceerd tussen december 2010 en augustus 2011 en bedoeld voor gebruik met de GVL analoge GlideScope monitor 0570 0200 0231 0003 De betreffende productiebatches van deze terugname zijn GlideScope GVL 3 Artikelnummer Serienummers 0574 0007 MD105000 tot MD112387 GlideScope GVL 4 Artikelnummer Serienummers 0574 0001 LG105000 tot LG112758 GlideScop
140. uit mentionn plus haut ainsi que toutes les personnes susceptibles d en tre inform es aient bien pris connaissance de cette notification de s curit urgente Si vous avez d livr ces produits des tiers veuillez leur transmettre une copie de cette information et contacter la personne dont les coordonn es sont indiqu es ci dessous Veuillez conserver cette information tant que les mesures correctives n ont pas t achev es L agence nationale de s curit du m dicament et des produits de sant a recu une copie de cette communication Contact Si vous tes un Client final veuillez vous adresser votre revendeur ou distributeur afin que celui ci proc de un change Si vous tes un revendeur sp cialis ou un distributeur veuillez vous adresser votre charg de client le du service Clients durant les horaires d ouverture habituels pour effectuer la reprise des produits Vous trouverez de plus amples informations sur cette proc dure la page suivante Pour toutes questions compl mentaires veuillez vous adresser Carola Janisch Manager Customer Service T l phone 49 8152 38 0 Fax 49 8152 38 202 Email info heine com Nous souhaitons pour finir souligner le fait que nous regrettons fortement cette situation et que nous vous prions de nous excuser pour la perte de temps et les d sagr ments que cela pourrait entrainer Nous vous remercions en m me temps de votre aide et de votre soutien Cordial
141. ure Please sign this document create a PDF and return to call center stereotaxis com
142. usmentionn soit effectu Si vous avez vendu ce systeme et qu il n est plus en votre possession nous vous prions de transmettre cette note de s curit au nouveau propri taire Veuillez galement nous communiquer les coordonn es du nouveau propri taire du syst me En vous remerciant pour votre compr hension et votre collaboration nous vous prions d agr er Formule l expression de nos salutations distingu es Siemens soci t anonyme Rob Reijn Stefaan De Moor Service Modality Manager Service Director Page 2 de2 SI EM ENS Healthcare Siemens nv Marie Curiesquare 30 1070 Brussel Belgi Naam Rob Reijn Divisie Customer Service Division AANGETEKEND Etablissement N Tel 02 536 46 10 02 536 46 74 Fonction GSM Rue E mail Marion wesendonk siemens com Ville Uw referentie Onze referentie H IM RR mw P 1122 Datum 10 augustus 2012 Veiligheidsadvies betreffende syngo plaza incorrecte berekening van de grijs waarde voor beelden met een pixeldiepte boven de 12 bits Formule Met deze brief wensen wij u te informeren over een storing bij het gebruik van syngo plaza In sommige omstandigheden wordt de grijswaarde in de functies Region of Interest Pixel Lens Edge enhancement en Histograms verkeerd berekend Wanneer treedt dit probleem op De minimale maximale waarde van de pixeldichtheid in de functies Region of Interest Pixel Lens Edge enhancement en Hi
143. ustomer Safety Advisory Notice Re Use of Flex Large 4 Coil on MAGNETOM Skyra Verio Spectra and Biograph mMR Dear MAGNETOM user This letter is intended to inform you about a potential safety issue regarding the Flex Large 4 Coil part No 8625761 in combination with your system when applied in a very specific position What was found and what is the potential risk When positioning the coil off center in left right direction as it is used for example for hip and shoulder imaging and in addition at an off center position with respect to the head foot direction the coil can heat up in the area of the electronic housing white plastic lids To be more precise heating may occur if each of the following conditions applies at the same time coil positioned off center in head foot direction by more than 5 cm Coil at side position application of high RF power over several minutes In that position the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient This effect has been identified in lab measurements only No customer incident has been reported until now as this coil setup is typically not used in routine patient examinations However a residual risk remains when the coil is positioned in this way especially when e g a sedated patient is examined who is not able to use the squeeze ball Siemens AG Allee am R thelheimpark 2 Tel 49 8131 84 0 Hea
144. workflow need to occur in the following order for this error to occur 1 Achange in the Field of View to a diameter other than the default 10mm AND 2 Aninterruption of the signal between the catheter and the system that is less than five 5 seconds in duration AND 3 Userthen selects the Adjust Image screen or pushes either the NearVu button or ChromaFlo button Volcano Corporation Page 1 of 5 August 2012 VOLCANO A signal interrupt is introduced through a loose or damaged connector A loose cable connection is quickly and easily avoided by ensuring a tight fit between the cables and the devices to which they are connected It should also be noted that a signal interrupt of five 5 seconds or longer will cause the system to go to a No Catheter mode which will result in the system correcting itself How To Avoid The Error If you do not change the FOV from the normal default 10mm diameter the error cannot occur If possible you should only use normal default FOV until the software patch is deployed In addition if you only use gray scale for review of the vessel the image quality is not affected whereas drawing borders and graticules are affected If you must change the FOV follow these steps Verify the FOV setting on the Adjust Image screen Refer to Image 1 e Ifthe system indicates 10mm simply adjust using the up arrow or the down arrow to the desired FOV before recording e Confirm your measur
145. x CH 8404 Winterthur Phone 41 0 52 262 60 70 Fax 41 0 52 262 03 64 www zimmer com As stated above we ask you to check the patient label by comparing its information to the product label during the surgery However if the patient label should not match with the product label we kindiy ask you to follow these instructions 1 Use whatever your institutional protocol is to manually record patient information using the correct information contained on the outer box label 2 Report the error to Zimmer Distribution of this Field Safety Notice This notice needs to be distributed to all personnel within your organisation who need to be aware or to any organisation where the potentially affected devices have been transferred to Contact reference person or local contact person Anne Catherine Morancy Meister Sr Postmarket Surveillance Engineer Zimmer GmbH Sulzer All e 8404 Winterthur Switzerland Tel 41 52 262 72 45 anne morancy zimmer com This notice has been notified to the appropriate Regulatory Agencies Winterthur 6 August 2012 Page 3 of 3 Smith 8 Nephew T 01480 423200 ith Cardinal Park F 01480 423201 ra We are smith amp nephew Godmanchester www smith nephew com Huntingdon Cambridgeshire PE29 2SN August 2012 Urgent Medical Device Recall Smith amp Nephew Advanced Surgical Devices Endoscopy metal and peek suture anchors Dear Customer This letter is to inform you of a voluntary
146. y brighter from previous recordings and you will not be able to modify this image by adjusting the gain e The Catheter mask center of the tomographic display will increase in size by 1 5x and will have an unnatural appearance i e no blood speckle e The image has a zoomed in appearance and becomes more obvious as the FOV increases beyond 10mm e The PIMr reset will cause the LED lights to turn off and on providing the users who work with the PIMr a visual cue that the PIMr is resetting The images below were taken at the same point in the vessel the correct image identified as Image before error is displayed on the left and the Incorrect image identified as Image after the error is displayed on the right Volcano Corporation Page 4 of 5 August 2012 YVOLCANO Image before error Bi Image after error ff Once the errors have occurred any images captured in a Video Loop or Still Frame cannot be corrected Affected Video Loops or Still frames can be detected by verifying whether the presence of a white ring as shown in the right hand picture of Image 3 Volcano Corporation Page 5 of 5 August 2012 SI E M E N S Healthcare Siemens AG H IM MR QM DCU Allee am R thelheimpark 2 91052 Erlangen Mame Georg Frese Department H IM MR QM DCU Telephone 49 8131 84 8099 To all users of Siemens Flex Large 4 Coil for nd ce nn La mai i ns MAGNETOM Skyra Verio Spectra and ins Biograph mMR Date 5 Sept 2012 C

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