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 003 12 11 000
Date submitted:	12/3/2011

Manufacturer:	GE Healthcare
Device Type:	X-Ray Diffraction Systems
Description:	Diffractometers, X-Ray
Medical Device Identifier:	Revolution XRD (X-Ray Diffraction) Systems All systems
Reason of Field Safety Corrective Action:	GE states that The hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. Should this happen during patient loading or unloading, patient injury could occur.
Remedy Action:	GE Healthcare will adjust the hand grip accessory on all affected units to ensure effective clamping of hand grip to table top. This activity will be performed at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh , (01) 4600530
Report Source:	NCMDR
Source Ref. Number:	1685F784FD313
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare_FSN_English.pdf

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