GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general… — Class II medical device recall Z-0841-2015
Terminated recall by GE OEC Medical Systems, Inc, reported 2015-01-21. mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube
| Recall number | Z-0841-2015 |
|---|---|
| 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 | 2014-09-15 |
| Classified | 2015-01-12 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-05-20 |
| Quantity | 61 units |
| Reason classes | labeling |
| Serial numbers | B4S13011, B4S13012, B4S13016, B4S13018, B4S13020, B4S13029, B4S13031, B4S13035, B4S13038, B4S13043, B4S13054, B4S13056, B4S13059, B4S13061, B4S14002, B4S14004, B4S14007, B4S14015, B4S14016, B4S14022, B4S1403 |
Product
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Reason for recall
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
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.