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 104 03 12 000
Date submitted:	3/25/2012

Manufacturer:	GE Medical Systems
Device Type:	Optima MR450W with GEM option, MRI
Description:	MRI, systems, RF
Medical Device Identifier:	Model number: 5410917 MR450W
Reason of Field Safety Corrective Action:	During scanning of a patient, if an improperly torqued gradient connection exists, it may cause the gradient lead to produce excessive heat. And if a second and compounding issue of improperly routed Rear Pedestal Air Supply Hose is also present, routed in such a way to cause the hose to come in contact with the overheated gradient lead cable, then the hose may generate smoke.
Remedy Action:	Field action to inspect (and correct if needed) the routing of the air hose of the system to ensure that it is routed per the existing service documentation.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh, (01) 4600530
Report Source:	NCMDR
Source Ref. Number:	954D7D34631F6
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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