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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 088 12 11 000
Date submitted: 12/21/2011
Manufacturer:GE Healthcare
Device Type:Radiographic Systems, Definium 8000 and Discovery XR650 Patient Barrier
Description:Radiographic Systems, Digital
Medical Device Identifier:Definium 8000 and Discovery XR650 systems with Image Pasting Option
Reason of Field Safety Corrective Action:Patient Barrier Rotating Arm may fail to retain residual friction at the arm pivot. This could permit the arm to swing freely.
Remedy Action:GE Healthcare states that they will modify the rotating arms to restore the residual friction so that the arm will retain position while the locking levers are disengaged. The product labeling will also be updated. A GE Healthcare service representative will contact you to arrange for this correction, at no cost. GE Healthcare stated the following instructions: 1. The patient barrier may continue to be used if the rotating arm locking lever securely holds the rotating arm in place when it is engaged. 2. Discontinue use of the patient barrier and remove from service (away from patients) if either one of the rotating arm locking levers is damaged (does not hold the rotating arm I place when engaged). 3. Take extra precautions to hold the patient barrier rotating arm during release of the locking lever and repositioning of the arm. 4. Store the rotating arms in the lowest pivot position (down) when not in use.
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh , (01) 4600530
Report Source:NCMDR
Source Ref. Number:9FD2A6EB9B39D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf