GE Brivo OEC715/785/865 C-Arm — Class II medical device recall Z-0066-2014
Terminated recall by GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD, reported 2013-10-30, distributed nationwide. GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high v
| Recall number | Z-0066-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD, Beijing, N/A, China |
| Recall initiated | 2013-09-18 |
| Classified | 2013-10-24 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, CN, DE, ES, FR, HU, IE, IN, JP, MY |
| Quantity | 29 |
| Serial numbers | B2S13001, B2S13010, B3S13005, B3S13008, B4S13001, B4S13015 |
| Model numbers | 715 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.