Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog… — Class II medical device recall Z-0070-2017
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2016-10-19, distributed nationwide. O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
| Recall number | Z-0070-2017 |
|---|---|
| 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 | 2016-09-22 |
| Classified | 2016-10-11 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Quantity | 14 units |
| Serial numbers | C0930, C0981, C0986, C1002, C1043, C1050, C1069, C1074, C1113, C1144, C1145, C1162, C1163, C1208 |
| Model numbers | BI-700-02000 |
Product
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
Reason for recall
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Machine access
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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.