Medtronic O-arm Imaging System Mobile X-ray system — Class II medical device recall Z-0973-2014
Terminated recall by Medtronic Navigation, Inc., reported 2014-03-12, distributed nationwide. Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to
| Recall number | Z-0973-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Littleton, MA, United States |
| Recall initiated | 2013-07-25 |
| Classified | 2014-02-28 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2019-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 449 in |
| Reason classes | labeling |
| Model numbers | 0-ARM, BI-700-00027, BI-700-00028 |
Product
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
Reason for recall
Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(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-0973-2014. 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.