Device recall
Z-1682-2021: Pentax Medical Video Duodenoscope - Product Usage: intended to be used with…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-1682-2021 |
|---|---|
| Recall event | 87763 |
| Product | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2. |
| Product code | FDT |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2024 |
| 510(k) numbers | K192245, K210710 |
| 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