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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 085 06 11 000
Date submitted: 6/25/2011
Manufacturer:GE Healthcare
Device Type:Magnetic Resonance Imaging, Optima and Brivo.
Description:Magnetic Resonance Imaging System, System cabinet.
Medical Device Identifier:Optima MR360/Brivo MR355 manufactured before April 8, 2011. Model Number: 5323286
Reason of Field Safety Corrective Action:There is a potential that the hoist tool welds could break, during the replacement of the XFD-PS, because of poor welding quality. If the hoist tool welds break, there is a possibility that the XFD-PS could fall to the ground, which could cause a hand or foot injury to service personnel.
Remedy Action:Your local service representative will contact you to install a modified hoist base on your Optima MR360/Brivo MR355 system. When using the Fixed Site Lift Tool Kit 46-317266 (hoist) to replace the XFD-PS follow the precautions from the hoist operation service replacement procedure.
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh, (01) 4600530
Report Source:NCMDR
Source Ref. Number:E1E459BD49324
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf