Urgent Field Safety Notice GE Healthcare
Contents
1. GE Healthcare Healthcare Systems Urgent Field Safety Notice 9900 Innovation Drive Wauwatosa WI 53226 USA GE Healthcare Ref FMI 17108 lt Date gt 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 Issue Safety Instructions Affected Product Details Product Correction FMI 17108_FSN_English GE Healthcare has recently become aware of a bucky device having restricted 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 If you observe any abnormal bucky movement or noises during the movement of your Proteus XR a X ray imaging system wall stand immediately stop using your system and contact your local GE Healthcare Service Representative Proteus XR a X ray imaging systems manufactured with wall stand model number 2260354 See attached addendum page 3 for instructio2. 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 Acting Chief Medical Officer GE Healthcare Vice President Devices GE Healthcare FMI 17108_FSN_English 2 3 1 Addendum Instructions for locating Wall stand Model number 2260354 Locate wall stand and stand on the left hand side of wall stand column The label is located in the bottom of wall stand column see Figure 1 Model number is printed on the Label Figure 1 FMI 17108_FSN_English 3 3
3. ection 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 desired XR Products Prestige SI Prestilix Processor Proteus XR a Proteus XR e XR i BRX Select all desired Select all desired Manual Types Classifications Quality Control Manual 4 General Class A Quick Guide Release Notes Renewal Parts Schematic Diagrams desired Status PSa0d Service Information Letter R500 Service Manual RAD Generator Specification RAD TMX System Service Manual RapidScan Troubleshooting Manual Revolution XQ i Upgrade Document Revolution XR d User Manual 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 Clear Contact If you have any questions regarding this Field Safety Notice or the identification of affected items please Information contact your local sales service representative GE Healthcare confirms that this notice has been notified to the appropriate
4. ns to locate the model number of your system GE Healthcare will inspect and repair as necessary all affected systems at no cost to 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 serviet ClientServiet REQ Enter Documentation Library See details on the next page 1 3 On the home page select and click on XR X ray 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 Support Multi Vendor PM AW Interventional Mammo Lunar DXA FAQ OR Search Dir
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