Device recall
Z-1489-2012: EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-1489-2012 |
|---|---|
| Recall event | 61613 |
| Product | EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs… |
| Product code | ITX |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2015 |
| 510(k) numbers | K090197 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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