Proteus XR/a and Revolution XR/d systems.
Contents
1. GE Healthcare Healthcare Systems Urgent Field Safety Notice 9900 Innovation Drive Wauwatosa WI 53226 USA GE Healthcare Ref FMI 17099 2 lt Date gt To Hospital Administrators Risk Managers Managers of Radiology Cardiology Radiologists Cardiologists RE Service Procedure Update Notice for Proteus XR a and Revolution XR d systems GE Healthcare is in the process of performing device updates to your GE Healthcare Proteus XR a and or Revolution XR d X ray systems related to collimator re installation errors The purpose of this second communication is to supply you with the Internet access link to the updated service procedures 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 The Proteus XR a and or Revolution XR d X ray service manuals at your site may not contain the latest collimator servicing instructions These servicing instructions have been updated to further ensure proper re installation Reinstallation errors may result in a fall of a collimator while the system is in use resulting in an injury to a patient or operator There was a reported incident of a collimator fall which caused a serious patient injury Please ensure that the organization that services your equipment uses the latest version of the Service procedures as listed below Pre2. manual Select all Select all desired Select all desired Select all desired desired XR Products Manual Types Classitications Status All Pre Installabon General Class A Advarkage Windows Advantx Advarty amp innova Advartx Advarty Positioners All Interventional Systems All RAD and REF Products AMX 110 AMX 3 AMX 4 AMX d Product Data Sheet Propnetary Serace Manual Quality Control Manual Quick Guide Release Notes Renewal Parts Schematic Diagrams Service Information Letter Specification System Service Manual v ANO 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 F multiple words are entered the input is considered to be an exact phrase search If you have any questions regarding this Field Safety Notice or the identification of affected items please contact your local sales service representative Contact Information 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 Werner Van den Eynde M D Acting Chief Medical Officer GE Healthcare James Dennison Vice President QARA GE Healthcare Systems FMI 17099 2_FSN Service Doc_English 2 2
3. ventive Maintenance Manual e Proteus XR a 2273022 100 Rev 30 or greater PM 012 e Revolution XRD 2296990 100 Rev9 or greater Section 2 5 2 Installation Manual e Proteus XR a 2273022 100 Rev 30 or greater IST 014 IST 015 e Revolution XRD 2357602 100 Rev 10 or greater Section 7 7 Section 7 9 1 Proteus XR a X ray systems installed with collimator P N s 2261763 2261765 2 All Revolution XR d X ray systems You are being contacted because you have been identified as an owner of one or more of these systems The latest versions of the Service procedure are available on the Internet at http apps gehealthcare com serviet ClientServiet REQ Enter Documentation Library See details on the next page FMI 17099 2_FSN Service Doc_English 1 2 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 OEC Sub Acute Pre Clinical Common Life Support Multi Vendor PM Interventional Mammo Lunar DXA FAQ OR Search Direction Number or Document Name fo 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
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