OEC Brivo 715 Prime — Class II medical device recall Z-0071-2017
Terminated recall by GE OEC Medical Systems, Inc, reported 2016-10-19, distributed nationwide. GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential,
| Recall number | Z-0071-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2016-09-23 |
| Classified | 2016-10-11 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 148 total |
| Reason classes | device malfunction |
| Serial numbers | B2S15158, B2S15164, B2S15166, B2S15171, B2S15173, B2S15195, B2S15197, B2S15200, B2S15202, B2S16046, B2S16050, B2S16051GE, B3S15236, B3S15241, B3S15242, B3S15246, B3S15248, B3S15250, B3S15253, B3S15257, B3S15259, B3S15338, B3S15353, B3S15357, B3S15359 and 7 more |
Product
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC 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. The OEC Brivo is not indicated for interventional use.
Reason for recall
GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0071-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.