FDA Device recall Z-2244-2012
Medtronic O-arm¿ Imaging System
- FDA Device
- Class II
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class II recall of Medtronic O-arm¿ Imaging System by Medtronic Navigation, citing A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2244-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-11 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | AL, CO, FL, IA, MI, NC, NE, NY |
Product
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Reason
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
Identifiers
| code_info | Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2244-2012%22
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