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Recall Observatory FDA recall evidence

Device 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.

Z-0066-2014

September 18, 2013

Class II

Product summary

Firm
GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
Event
Event 66341
Status
Terminated
Classification
Class II
Quantity
29
Official record key
device-enforcement:Z-0066-2014

Official wording

Reason: 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.

Code information: GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.