Reported Oct 30, 2013 · Terminated
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray…
GE Healthcare Beijing , Hangwei Medical Systems, Co. Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD · No. 2 Yong Chang North Rd. · Beijing, N/A · N/A
Is this the product you have?
- GE Brivo OEC715/785/865 C-Arm
- Models715 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
- Lot codes and dates
- GE Brivo OEC715Serial Numbers B2S13001 ~ B2S13010
- GE Brivo OEC785Serial Numbers B3S13005 ~ B3S13008
- GE Brivo OEC865Serial Numbers B4S13001 ~ B4S13015
- Amount recalled
- 29
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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