Medtronic Navigation O-arm 02 surgical x-ray imaging system — Class II medical device recall Z-2083-2016
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2016-07-13, distributed nationwide. Review of on-system electronic product labeling and Instr uctions for Use in response to an internal managemen
| Recall number | Z-2083-2016 |
|---|---|
| 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 | 2016-03-17 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2021-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 63 |
| Reason classes | labeling |
| Model numbers | BT-700-02000 |
Product
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Reason for recall
Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
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-2083-2016. 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.