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1. the model Details number of your system Product GE Healthcare will inspect and repair as necessary all affected systems at no cost to Correction you A GE Healthcare service representative will contact you to arrange for this correction Additionally the Service Procedure which defines the service interval for periodic cable maintenance and replacement is being updated to require a cable replacement every 15 years and specify annual inspections of the counterweight guide rail bolt paint marking to confirm tightness of the bolt This is to ensure the ongoing safe operation of this device Please be sure to review and apply the updated Service Procedure maintenance instructions and ensure the Bucky wall stand steel cables of your Proteus XR a X ray imaging system are inspected and replaced as specified in the updated procedure Please see the updated Service Procedure 2273022 100 Rev 33 or above which will be available at the link shown below by 31 March 2015 http apps gehealthcare com servlet ClientServiet REQ Enter Documentation Li brary See details on the next page Page 1 of 3 Released Rendered PDF File Page 3 of 4 DOC1657960 Rev 1 On the home page Select and click on XR to launch the search Common Documentation Library Locate documents in the Common Documentation Library via Search criteria CT MR NM PET US XR Radiopharmacy Cardiology CIS Clinical Systems IIS OEC Sub Acute Pre Clinical Common Life Supp2. Released Rendered PDF File Page 2 of 4 DOC1657960 Rev 1 GE Healthcare URGENT MEDICAL DEVICE CORRECTION 2900 Innovation Drive Wauwatosa WI 53226 USA lt Date of Letter Deployment gt GEHC Ref 17108 To Hospital Administrators Risk Managers Managers of Radiology Cardiology Radiologists Cardiologists RE Proteus XR a X ray imaging systems Potential cable breakage of the wall stand steel cable GE Healthcare has recently become aware of a potential safety issue involving the breakage of the steel cable which support the bucky device in certain wall stands of Proteus XR a X ray imaging systems Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions Safety GE Healthcare has recently become aware of a bucky device having restricted Issue vertical movement which results in a breakage of Its supporting cable A fall of a bucky while the system is in use could result in an injury to a patient or operator There were no injuries reported as a result of this issue Safety If you observe any abnormal bucky movement or noises during the movement of Instructions your Proteus XR a X ray imaging system wall stand immediately stop using your system and contact your local GE Healthcare Service Representative Affected Proteus XR a X ray imaging systems manufactured with wall stand model number Product 2260354 See attached addendum page 3 for instructions to locate
3. ort Multi Vendor PM AW Interventional Mammo Lunar DXA FAQ OR Search Direction Number or Document Name foo Search Help Note This search method is case insensitive you may enter upper or lower case If multiple words are entered the input is considered to be an exact phrase search Search Select your X Ray Imaging product from the list and choose Service Manual from the Manual Type and click on Search to launch the search to bring up the proper service manual Select all Select all desired Select all desired Select all desired desired XR Products Manual Types Classifications Status Prestige SI A Quality Control Manual A General Class A New Prestilix Quick Guide Processor Release Notes CD Proteus XR a Renewal Parts Obsolete Proteus XR e XR i BRX Schematic Diagrams P5800 Service Information Letter R500 Service Manual RAD Generator Specification RAD TMX E System Service Manual d RapidScan Troubleshooting Manual Revolution XQ i Upgrade Document Revolution XR d v User Manual v AND additional search term Search Direction Number or Document Name Search Help Note This search method is case insensitive you may enter upper or lower case If multiple words are entered the input is considered to be an exact phrase search Contact If you have any questions or concerns regarding this notification please call the Information following phone number United States 800 437 1171 For other coun
4. tries please contact your local GE Healthcare Service Representative 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 per the contact information above Sincerely James W Dennison Werner Van den Eynde M D Vice President Devices Acting Chief Medical Officer GE Healthcare GE Healthcare Page 2 of 3 Released Rendered PDF File Page 4 of 4 DOC1657960 Rev 1 Addendum Instructions for locating Wall stand Model number 2260354 1 Locate wallstand and stand on the Left hand side of wall stand column The label is located in the bottom of wallstand column see Figure 1 Model number is printed on the Label Figure 1 Page 3 of 3
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