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 187 02 12 000
Date submitted:	2/29/2012

Manufacturer:	GE Healthcare
Device Type:	X-ray system, diagnostic. Series 7600/7700 Mobile C-Arm,, Interconnect PO Cable
Description:	X-ray system, diagnostic, fluoroscopic, general purpose, mobile, digital
Medical Device Identifier:	Series 7600/7700 Mobile C-Arm, Compact 7600/7700 Mobile C-Arm, Compact 7700 Plus Mobile C-Arm. Used with interconnect PO Cable part number: 00-452118-01 or 00-453118-01. Serial Number range: 2457-2632.
Reason of Field Safety Corrective Action:	The interconnect PO Cable that connects the C-arm to the monitor cart may fail, resulting in loss of video signal transmission to the monitors.
Remedy Action:	Avoid making sharp or low angle bends with the PO interconnect cable. GE Healthcare will arrange for replacement of the interconnect cable at no charge.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh, (01) 4600530
Report Source:	NCMDR
Source Ref. Number:	AA38391DA91E1
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare.pdf

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