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O-ARM®
MEDTRONIC NAVIGATION, INC. · Model BI70002000 · UDI-DI 00763000355609
10
510(k) clearances
10,986
Adverse events (8 deaths)
49
Recalls
68
Facilities
Description
O-ARM SYS BI70002000 O2 UE 240V F EN EN
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-21 | GE Medical Systems, LLC | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2025-03-21 | GE Medical Systems, LLC | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in th |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in th |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in th |
| 2021-06-10 | GE OEC Medical Systems, Inc | There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.