Device recall
Z-0767-2020: O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
FDA device recall · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Recall number (Z-number) | Z-0767-2020 |
|---|---|
| Recall event | 84441 |
| Product | O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 |
| Product code | OWB |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 19, 2023 |
| 510(k) numbers | K151000, K173664 |
| FEI number | 3004785967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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