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O-arm O2
MEDTRONIC NAVIGATION, INC. · Model BI70002000 · UDI-DI 00763000863302
10
510(k) clearances
49,979
Adverse events (105 deaths)
624
Recalls
121
Facilities
Description
O-ARM SYS BI70002000 O2 UE 120V B EN UEN
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-04 | Canon Medical System, USA, INC. | Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. |
| 2026-07-16 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropr |
| 2026-07-16 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications an |
| 2026-06-29 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Firmware issue potentially leading to loss of geometry movements. |
| 2026-06-17 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| 2026-06-17 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| 2026-06-17 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| 2026-06-11 | Oxos Medical Inc | Due to a defective circuit board that overheats |
| 2026-06-08 | Siemens Medical Solutions USA, Inc | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradual |
| 2026-05-20 | Siemens Medical Solutions USA, Inc | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. |
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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.