Device recall
Z-0643-2018: Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-0643-2018 |
|---|---|
| Recall event | 79237 |
| Product | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to… |
| Product code | FDT |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2020 |
| 510(k) numbers | K092710, K161222 |
| 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