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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 097 12 11 000
Date submitted: 12/26/2011
Manufacturer:GE Healthcare
Device Type:X-Ray System, diagnostic. OEC Fluorostar
Description:X-Ray System, diagnostic, fluoroscopic, angiographic, mobile, digital
Medical Device Identifier:GE OEC Fluorostar 7900, software versions 02.08.01 - 02.08.08.
Reason of Field Safety Corrective Action:An issue has been discovered that can result in lock-up of the touch panel.
Remedy Action:A GE service representative will be contacting the customers in the near future to arrange for installation of the corrective software at no charge. For the mean time, please do not press buttons on the touch panel during the Cine Save process. Cine Save progress is visible as a numeric text % in the bottom status bar and as a moving bar on the perimeter of the image.
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh , (01) 4600530
Report Source:MHRA
Source Ref. Number:4F46392904FB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf