GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD: Medical Device Recall in 2013 - (Recall #: Z-0066-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 18, 2013

Date Posted: October 30, 2013

Recall Number: Z-0066-2014

Event ID: 66341

Reason for Recall:

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.

Status: Terminated

Product Quantity: 29

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.

Voluntary or Mandated:

Voluntary: Firm initiated