Urgent Safety Notice for the Digital Radiography X-Ray
Contents
1. NV Septestraat 27 B 2640 Mortsel Belgium URGENT SAFETY NOTICE lt lt Reason for notification gt gt Page 2 3 Agfa HealthCare Insert country regional legal entity address here remove this guidance from final document AGFA lt gt PR1406020002 URGENT SAFETY NOTICE FEEDBACK FORM We kindly ask you to send back the attached information as soon as possible Thank you for your co operation Customer Facility Name lA _Customer_Name lA_Facility_ Site Address lA Street_ Address lA_City IA _State lA Zip Code Notice Reference PR1406020002 Product Reference DX D100 _ lconfirm that have received and understand the attached notice _ This notice does not apply to my facility _ The device has been transferred to another organization Customer Name Position Signature Date Phone number Please correct our contact information as follows Customer Facility Name Address Fax this completed form to lt fax no gt or email us on lt email address gt indicating the reference code above in the subject line Agfa HealthCare Insert country regional legal entity address here remove this guidance from final document2. AGFA lt gt PR1406020002 URGENT FIELD SAFETY NOTICE lA Customer_Name lA _Facility_ Site lA Street_Address lA City IA State lA Zip Code Caution Digital Radiography X Ray System DX D 100 Unintentional touch screen activation due to liquids Dear customer Agfa HealthCare wishes to bring to your attention the following information which has also been communicated to the Competent Authority of your country Device This notice refers to the mobile Digital Radiography X Ray System unit DX D 100 Problem When liquid comes in contact with the DX D 100 touch screen the device may incorrectly recognize this as user input altering device settings Background information Capacitive touch screens rely on the electrical properties of the human body to enable you to operate the device with very light touches of a finger However when liquid comes in contact with the touch screen it may incorrectly recognize this as user input For example it could unexpectedly change the exposure seitings Actions Although medical staff are required to disinfect hands on a frequent basis users must ensure their hands are dry before using the touch screen of the DX D100 because liquid residue may activate the action buttons on the touch screen e Do not operate touch screen monitor with wet hands e Do not let liquids come in contact with the touch screen while the DXD 100 is powered on e Always double check you
3. r parameter settings prior to exposing the patient We would like to remind you of this specific warning statement in the DX D100 User Manual URGENT SAFETY NOTICE lt lt Reason for notification gt gt Page 1 3 Agfa HealthCare Insert country regional legal entity address here remove this guidance from final document AGFA lt gt PR1406020002 DX D 100 Mobile X Ray Unit User Manual page 11 IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THAT ALL THE EXPOSURE PARAMETERS ARE CORRECT BEFORE PERFORMING AN EXAM TO THE PATIENT BY VERIFYING THAT THE PARAMETER SELECTION HAS NOT BEEN MODIFIED UNINTENTIONALLY OR BY THE CONTACT OF EXTERNAL ELEMENTS ON THE CONTROL CONSOLE IN ORDER TO AVOID THE OVEREXPOSURE OR THE NEED OF PERFORMING A NEW EXAM TO THE PATIENT Please complete the feedback form as soon as possible and return it to us Should the above information not apply to your facility or should the device have been transferred to another organization please be so kind as to indicate this on the attached feedback form and pass this Urgent Field Safety Notice to the organization where the device has been transferred We thank you for your careful attention to this issue and your continued support If you have any questions about this matter please contact your local Agfa HealthCare organization lt Name of contact person gt at lt Tel gt Sincerely EE Head of QARA Imaging Business Division Agfa HealthCare
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