O-arm O2 Imaging System — Class II medical device recall Z-2101-2025
Ongoing recall by Medtronic Navigation, Inc.-Boxborough, reported 2025-07-16, distributed nationwide. A mechanical component that supports the O2 gantry to the support structure in affected devices may have been
| Recall number | Z-2101-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc.-Boxborough, Boxborough, MA, United States |
| Recall initiated | 2025-05-27 |
| Classified | 2025-07-09 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| UPC / GTIN / UDI-DI | 00763000709631 |
| Serial numbers | C4014, C4017, C4019 |
Product
O-arm O2 Imaging System. Mobile X-Ray System.
Reason for recall
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
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-2101-2025. 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.