FDA Device recall Z-2101-2025
O-arm O2 Imaging System
- FDA Device
- Class II
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class II recall of O-arm O2 Imaging System by Medtronic Navigation Boxborough, citing A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2101-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-27 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Navigation Boxborough |
| Distribution | US |
Product
O-arm O2 Imaging System. Mobile X-Ray System.
Reason
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Identifiers
| code_info | CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2101-2025%22
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