Device recall
Z-2116-2014: EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-2116-2014 |
|---|---|
| Recall event | 68586 |
| Product | EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract. |
| Product code | FDS |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2015 |
| 510(k) numbers | K041396 |
| 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