Device recall
Z-1238-2025: Pentax Medical Video Processor- Intended to be used with PENTAX Medical…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-1238-2025 |
|---|---|
| Recall event | 96164 |
| Product | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c |
| Product code | PEA |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K231249 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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