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O-ARM®
MEDTRONIC NAVIGATION, INC. · Model BI90000048 · UDI-DI 20643169525874
OWB
Prescription
10
510(k) clearances
50,677
Adverse events (108 deaths)
638
Recalls
127
Facilities
Description
MOUSE BI90000048 OARM WIRELESS 10PK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-10-12 | Canon Medical System, USA, INC. | Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use. |
| 2026-10-12 | Canon Medical System, USA, INC. | Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use. |
| 2026-10-12 | Canon Medical System, USA, INC. | Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use. |
| 2026-10-06 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which |
| 2026-10-06 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which |
| 2026-10-06 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which |
| 2026-10-06 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which |
| 2026-10-06 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which |
| 2026-10-06 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which |
| 2026-10-06 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which |
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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.