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 001 03 12 000
Date submitted:	3/3/2012

Manufacturer:	GE Healthcare
Device Type:	Gamma camera, stationary. Infinia Nuclear Medicine systems,
Description:	Nuclear medicine system, gamma camera, stationary
Medical Device Identifier:	GEHC Infinia Nuclear Medicine systems, all configurations.
Reason of Field Safety Corrective Action:	GE Healthcare found that in rare cases the Infinia lateral gear does not meet engineering design specifications. This may cause accelerated fatigue of the lateral axis motion subsystem which may lead to a detector sliding during lateral movement, which could potentially introduce a patient or operator to direct impact associated with permanent impairment.
Remedy Action:	A GE Service Representative will contact you to schedule a lateral axis gear alignment test. In rare cases, the test outcome might require the replacement of both the lateral gear and the lateral lead screw.
Athorized Representative/Importer/Distributor:	GE Healthcare, Riyadh, (01) 4600530
Report Source:	NCMDR
Source Ref. Number:	9D2C4DD6EF2DB
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare.pdf

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