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 013 09 16 000
Date submitted:	9/20/2016

Manufacturer:	GE Healthcare
Device Type:	MAGiC on Signa Pioneer and systems running Application software version DV25.1.
Description:	MAGnetic resonance image Compilation
Medical Device Identifier:	MAGiC (MAGnetic resonance image Compilation) on Signa Pioneer and systems running Application software version DV25.1.
Reason of Field Safety Corrective Action:	Images may exhibit novel artifacts on MAGiC T2 FLAIR synthetic reconstructions, that may be difficult to recognize without access to conventional T2 FLAIR weighted images.
Remedy Action:	GE Healthcare will correct all affected products at no cost to you. You will receive new MAGiC operator documentation Release Notes.
Athorized Representative/Importer/Distributor:	GE Healthcare
Report Source:	NCMDR
Source Ref. Number:	AE2E062F4915A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare.pdf

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