Medtronic O-arm¿ Imaging System — Class II medical device recall Z-2244-2012
Terminated recall by Medtronic Navigation, Inc., reported 2012-08-29, distributed in AL, CO, FL, IA, MI, NC, NE, NY. A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
| Recall number | Z-2244-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Littleton, MA, United States |
| Recall initiated | 2012-07-11 |
| Classified | 2012-08-22 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2016-06-06 |
| Distributed | AL, CO, FL, IA, MI, NC, NE, NY |
| Countries outside the US | ES, IT, ZA |
| Quantity | 17 units |
| Reason classes | device malfunction |
| Serial numbers | 109R, 118R, 124, 136, 159, 170, 218, 222, 223, 236, 239, 299, 309R, 402, 410, 412, 414 |
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 for recall
A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
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-2244-2012. 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.