Medtronic O-arm O2 Imaging System — Class II medical device recall Z-2451-2026
Ongoing recall by Medtronic Navigation, Inc.-Boxborough, reported 2026-06-24, distributed nationwide. Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
| Recall number | Z-2451-2026 |
|---|---|
| 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 | 2026-05-19 |
| Classified | 2026-06-15 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, GT, HK, ID, IL, IN, IQ, IT, JO, JP, KR, KW, MA, MX, MY, NL, NP, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, VN |
| Quantity | 589 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00643169639683, 00643169651814, 00763000132378, 00763000355555, 00763000481599, 00763000496586, 00763000496593, 00763000496609, 00763000496630, 00763000496647, 00763000496661, 00763000496678, 00763000496692, 00763000496708, 00763000496715, 00763000496722, 00763000616304, 00763000616397, 00763000616441, 00763000616458, 00763000616564, 00763000709365, 00763000709372, 00763000709389, 00763000709396 and 32 more |
| Serial numbers | 00643169639683, 00643169651814, 00763000132378, 00763000355555, 00763000481599, 00763000496586, 00763000496593, 00763000496609, 00763000496630, 00763000496647, 00763000496661, 00763000496678, 00763000496692, 00763000496708, 00763000496715, 00763000496722, 00763000616304, 00763000616397, 00763000616441, 00763000616458, 00763000616564, 00763000709365, 00763000709372, 00763000709389, 00763000709396 and 475 more |
| Model numbers | BI70002000 |
Product
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Reason for recall
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
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-2451-2026. 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.