Medtronic 0-arm Imaging System with Software Version 3 — Class II medical device recall Z-1849-2012
Terminated recall by Medtronic Navigation, Inc., reported 2012-06-27, distributed nationwide. Software Version 3.1.1 does not meet navigational accuracy.
| Recall number | Z-1849-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Littleton, MA, United States |
| Recall initiated | 2010-10-12 |
| Classified | 2012-06-21 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2012-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | software |
| Serial numbers | 125, 156, 234R |
| Model numbers | BI-700-00027-120, BI-700-00027-120R |
Product
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Reason for recall
Software Version 3.1.1 does not meet navigational accuracy.
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-1849-2012. 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.