Device recall
Z-1932-2019: Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX…
FDA device recall · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Recall number (Z-number) | Z-1932-2019 |
|---|---|
| Recall event | 82991 |
| Product | Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE… |
| Product code | OXO |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2021 |
| 510(k) numbers | K092564 |
| FEI number | 3004785967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database