FDA Device recall Z-2082-2016
Medtronic 0-arm Imaging mobile x-ray system
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of Medtronic 0-arm Imaging mobile x-ray system by Medtronic Navigation Littleton, citing it has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2082-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-17 |
| Published | 2016-07-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation Littleton |
| Distribution | US |
Product
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Reason
It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
Identifiers
| code_info | Model No. BI-700-00027 and BT-700-00028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2082-2016%22
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