[Recalled] 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. — A fault in a high voltage relay in the 0-arm¿ Imaging System migh
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Medtronic Navigation, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2244-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 July 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.