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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 055 12 14 001
Date submitted: 2/5/2015
Manufacturer:GE Healthcare
Device Type:Proteus XR/a X-ray imaging systems
Description:mammographic applications, radiographic images, diagnostic
Medical Device Identifier:Proteus XR/a X-ray imaging systems with wall stand model number 600-0301 manufactured before January 2011. See attached addendum page 3 for instructions to locate the manufacture date of your system.

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NCMDR update codes :

Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.
Reason of Field Safety Corrective Action:GE Healthcare has recently become aware of a bucky device falling from the wall stand as a result of the breakage of its supporting cables.
Remedy Action:GE Healthcare will correct all affected systems by replacing the steel cables at no cost. A GE Healthcare service representative will contact you to arrange for this correction.

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NCMDR update action :

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/servlet/ClientServlet?REQ=Enter+Documentation+Library
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:AD2D12B9C1266, D554B22874277
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare (2).pdf