X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 012 05 11 000
Date submitted: 5/3/2011
Manufacturer:GE Healthcare
Device Type:Magnetic Resonance Systems
Description:The involved systems are whole body magnetic resonance scanners designed to support high resolution and high signal-to-noise ratio images in short exam times. They are indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
Medical Device Identifier:Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx. Signa HDxt, Signa HFO, GE 1.5T Signa HDe, GE 1.5T Signa HDsv, Signa Excite 1.5T & 3T All MRU units (5196918) shipped to the field between October/01/2009 – December/10/2010 will be included in the fix.
Reason of Field Safety Corrective Action:GE Healthcare has become aware that in the event of a significant power surge, such as one that might be caused by a lightning strike or a utility equipment failure; there is a possibility that the fuse in the MRU (Magnet Rundown Unit) circuit could be affected. This situation could indirectly lead to a potential hazard if an emergency magnet quench is required.
Remedy Action:GE Healthcare will correct all affected systems by providing a hardware resolution at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.
Athorized Representative/Importer/Distributor:GE Healthcare, Riyadh (01) 4600530
Report Source:NCMDR
Source Ref. Number:94A49CA57B2F4
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: FMI_60802_FSN_English[1].pdf