Device recall
Z-0293-2021: 9310HD Digital Video Capture Module with software version 3.4.0 or higher…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-0293-2021 |
|---|---|
| Recall event | 86440 |
| Product | 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal |
| Product code | OUG |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2022 |
| FEI number | 1000080301 |
At a glance
- None 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