SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 095 12 15 000
Date submitted:	12/23/2015

Manufacturer:	GE Healthcare
Device Type:	Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
Description:	X-Ray Imaging systems.
Medical Device Identifier:	All Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems.
Reason of Field Safety Corrective Action:	GE Healthcare has recently become aware of an issue related to the operation of the safety latch within the column that supports the horizontal arm. This safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. There have been no incidents or injuries reported as a result of this internally found issue.
Remedy Action:	You may continue to use the system. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:	GE Healthcare
Report Source:	NCMDR
Source Ref. Number:	4D5EC03A6F214
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare.pdf

View History