The Recall Desk
ModerateFDA (Devices)·Z-0066-2014·Announced 2013-10-30

GE Brivo C-Arm X-Ray Recalled for High Voltage Cable Failure

GE is recalling 29 Brivo C-Arm X-ray units because high voltage cable wires may fail, causing loss of system functionality.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a loss of system functionality due to cable failure, which is a functional defect rather than a direct physical injury or death risk, fitting the Moderate criteria for low-risk or functional issues without reported harm.

Plain-English summary

GE Healthcare Beijing, Hangwei Medical Systems, Co. LTD is recalling 29 units of the GE Brivo OEC715/785/865 C-Arm. The affected models are the 715 Prime, 785 Essential, and 865 Plus. These mobile C-Arm X-ray products are designed to provide digital spot film imaging and fluoroscopic image guidance for adult and pediatric populations during general surgical applications and musculoskeletal procedures.

The recall is due to the potential for the wires in the high voltage cable bundle to fail. This failure can result in a loss of system functionality. The affected units were distributed worldwide, including nationwide in the USA and internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.

The specific serial numbers affected are: GE Brivo OEC715 (B2S13001 through B2S13010), GE Brivo OEC785 (B3S13005 through B3S13008), and GE Brivo OEC865 (B4S13001 through B4S13015). Healthcare facilities should contact the recalling firm for instructions on how to address the defect.

The recalled product

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 a
Manufacturer
GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
Category
Medical Device — Imaging Equipment
Hazard
Affected units
29

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · electrical failure

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