Medtronic Navigation 0-arm 02 Imaging System interventional… — Class II medical device recall Z-0404-2019
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2018-11-14, distributed nationwide. O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acq
| Recall number | Z-0404-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc.-Littleton, Littleton, MA, United States |
| Recall initiated | 2018-09-17 |
| Classified | 2018-11-07 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-05-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BH, BR, CA, CH, CL, CO, DE, DK, ES, FI, FR, GB, IE, IL, IN, IS, IT, JO, JP, KR, LU, MX, NL, NZ, PL, PT, QA, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 641 units |
| Reason classes | labeling, software |
| Serial numbers | C0875 |
| Model numbers | BI70002000, BI70002000R |
Product
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Reason for recall
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
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-0404-2019. 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.