FDA Device recall Z-0841-2015
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize by Ge Oec Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0841-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-15 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | n/a |
Product
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Reason
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).
Identifiers
| code_info | GE OEC Brivo 865 Plus Serial Numbers: B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035…GE OEC Brivo 865 Plus Serial Numbers: B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035 B4S13038 B4S13043 B4S13054 B4S13056 B4S13059- B4S13061 B4S14002- B4S14004 B4S14007 B4S14015 B4S14016 B4S14022 B4S14022 B4S1403 3 B4S1403 4 |
|---|
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-0841-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.