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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 116 01 17 000
Date submitted: 1/27/2017
Manufacturer:GE Healthcare
Device Type:Discovery MR450 narrow bore 1.5T MRI
Description:MRI Coil
Medical Device Identifier:Discovery MR450, narrow bore 1.5T non-GEM.
Distribution dates: June 2009 through July 2016.
Reason of Field Safety Corrective Action: GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
Remedy Action:GE Healthcare will correct all affected products, at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:7DD4DC688531A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf