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GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD recalls GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Produ
Recalled October 30, 2013 · FDA recall Z-0066-2014 · GE Healthcare Beijing , Hangwei Medical Systems
Hazard
GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality. · FDA Class II
Units
29
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
Description
GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.
Product
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
Manufacturer(s)
GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →