Device recall
Z-1268-2020: Pentax Video Colonoscope Model: EC38-i10L
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-1268-2020 |
|---|---|
| Recall event | 84735 |
| Product | Pentax Video Colonoscope Model: EC38-i10L |
| Product code | FDF |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2021 |
| 510(k) numbers | K131855 |
| FEI number | 1000080301 |
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