Device recall
Z-2077-2016: Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-2077-2016 |
|---|---|
| Recall event | 73894 |
| Product | Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument… |
| Product code | ITX |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2017 |
| 510(k) numbers | K961974 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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