FDA Device recall Z-2083-2016
Medtronic Navigation O-arm 02 surgical x-ray imaging system
- FDA Device
- Class II
- terminated
- Published 2016-07-13
On 2016-07-13 the FDA classified a Class II recall of Medtronic Navigation O-arm 02 surgical x-ray imaging system by Medtronic Navigation Littleton, citing review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for info….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2083-2016 |
| 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 Navigation O-arm 02 surgical x-ray imaging system
Reason
Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
Identifiers
| code_info | model number BT-700-02000 |
|---|
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-2083-2016%22
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