Manufacturer`s FSN
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1. GE Healthcare Healthcare Systems Urgent Field Safety Notice 9900 Innovation Drive Wauwatosa WI 53226 USA GE Healthcare Ref FMI 40856 February 21 2014 To Managers of Nuclear Medicine Hospital Administrators Risk Managers Managers of Radiology Cardiology RE Unintended detector motion on Infinia and Infinia Hawkeye Nuclear Medicine systems Millennium VG VG Hawkeye and VariCam Nuclear Medicine systems GE Healthcare has recently become aware of a potential safety issue related to unintended radial detector motion which may occur during patient setup or at the end of a patient scan Please ensure that all potential users and service personnel in your facility are made aware of this safety notification and the recommended actions Safety Issue A potential life threatening hazardous situation may occur if there is unintended radial detector motion leading to patient contact This failure mode has been observed on a single system for a Whole Body scan in which the detector moved to the home position and then slowly started drifting inward toward the patient This generated both a visual and audio alert condition on both the console and the gantry No injuries have been reported to date This potential detector slippage is due to a combination of gear box self lock failure due to wear a malfunction in the brake electrical command circuit Safety Monitor the patient and the system during the entire scan procedure to ensure that th2. Notice ge com Attention GE Healthcare EMEA Customer Safety letters Specialist 283 rue de la Mini re 78530 Buc France FMI40856_Infinia FSN_English_UKI 3 3
3. ere is Instructions enough clearance between the patient and the detectors In the case that the detector comes into contact with the patient press the Detector Out button on the Remote Control Unit to reverse the motion of the detector In the case that any unintended motion of the detector is identified press the Emergency Off button either at the console or on the gantry shown below to halt this motion and pull the Patient Release Handle to extract the patient as directed in the user manual Using the Pressure Sensitive Devices at the gantry may not stop the detector unintended motion If you see error 147 in axis 1 please follow the user manual instructions and contact GE Service me Remote Control Unit Gantry Display Unit Pressure A f Sensitive Purr h Devices _ i ie i Sa VW J m o TE ki T ad l y a J i F i ee sy if f 2 m eh i lisa h h Detector Out Enable A W ia l Moves the detactor s away r m p from the patient nl Button ny Q O A AT FMI40856_Infinia FSN_English_UKI 1 3 Affected Product Details Product Correction Contact Information GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine systems Millennium VG VG Hawkeye and VariCam Nuclear Medicine systems all configurations A GE Healthcare Service representative will perform a software upgrade on each affected system This activity will be performed at no cost to you If you have any que
4. stions regarding this Field Safety Notice or the identification of affected items please contact your local Sales Service representative You can also contact Phil Walker Regional Support Engineer NM Mobile 44 0 7771 767106 e mail philip walker med ge com Paul Mardle RA Manager UK Ireland Phone 44 1707 263570 e mail paul mardle ge com GE Healthcare 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 James Dennison Vice President QARA GE Healthcare Systems Du n Sema Douglas M Hansell M D MPH Chief Medical Officer GE Healthcare FMI40856_Infinia FSN_English_UKI 2 3 GE Healthcare Ref FMI 40856 Infinia VG Varicam Customer Reply Form PLEASE COMPLETE and FAX to GE Healthcare CUSTOMER CONTACT INFORMATION Note please list all site locations and names if your responsible for more than one site or if your site is known by other names Thank you Site Name Street Address City State Postal Code a Country a By signing below acknowledge receipt of the letter and accept to follow and to apply the safety instructions Please record below the date on which your facility received this information Name and Title Signature Please FAX back to 44 0 1 75 341 7098 Or Email to Safety
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