Device recall
Z-2041-2020: ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as…
FDA device recall · Class III · Immersivetouch Inc
Key facts
| Recall number (Z-number) | Z-2041-2020 |
|---|---|
| Recall event | 85475 |
| Product | ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options |
| Product code | LLZ |
| Recalling firm | Immersivetouch Inc |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K140860 |
| FEI number | 3014833795 |
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