FDA Device recall Z-0066-2014
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus
- FDA Device
- Class II
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class II recall of GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus by Ge Healthcare Beijing Hangwei Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0066-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-18 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare Beijing Hangwei Medical Systems |
| Distribution | US |
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.
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.
Identifiers
| code_info | GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0066-2014%22
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