O-arm O2 Imaging System-Mobile x-ray system designed for 2D… — Class II medical device recall Z-2026-2024
Ongoing recall by Medtronic Navigation, Inc.-Littleton, reported 2024-06-12, distributed nationwide. Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can c
| Recall number | Z-2026-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc.-Littleton, Littleton, MA, United States |
| Recall initiated | 2024-04-26 |
| Classified | 2024-06-06 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, CA, CR, IN, MX, PA, PH |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 00643169639683, 00763000616441, 00763000616465, 00763000616526, 00763000616533, 00763000616564, 00763000616571 |
| Serial numbers | C1437, C1595, C1629, C3389, C3407, C3421, C3469, C3537, C3551, C3578, C3589, C3604, C3606, C3607, C3626, C3635, C3641, C3645, C3647, C3713 |
Product
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
Reason for recall
Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2026-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.