Medtronic 0-arm Imaging mobile x-ray system — Class II medical device recall Z-2082-2016
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2016-07-13, distributed nationwide. It has been discovered that replacement x-ray generator and system motion batteries could become damaged durin
| Recall number | Z-2082-2016 |
|---|---|
| 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 | 581 |
| Model numbers | B1-700-00027, B1-700-00028, BI-700-00027, BT-700-00028 |
Product
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Reason for recall
It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
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-2082-2016. 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.