SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 038 02 16 000
Date submitted:	2/14/2016

Manufacturer:	GE Healthcare
Device Type:	3.0T GEMflex Coil
Description:	Imaging device
Medical Device Identifier:	3.0T GEM Flex Coil 16-L Array 5430008-2 3.0T GEM Flex Coil 16-M Array 5430008-3 3.0T GEM Flex Coil 16-S Array 5430008-4 3.0T GEM Flex Interface 5430008-5
Reason of Field Safety Corrective Action:	Part of the cable assembly may overheat when the device is used. Rarely this could result in minor burn injury in case of prolonged direct skin contact with the overheating part.
Remedy Action:	GE Healthcare will collaborate with NeoCoil to correct all affected products at no cost to you. You will be contacted to arrange for the correction.
Athorized Representative/Importer/Distributor:	GE Healthcare
Report Source:	NCMDR
Source Ref. Number:	F7C1F0DD0838D
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE - Revised.pdf

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