Device recall
Z-2278-2016: Gastroscope Product Usage: Intended to provide optical visualization of and…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-2278-2016 |
|---|---|
| Recall event | 73985 |
| Product | Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when… |
| Product code | FDF |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2017 |
| 510(k) numbers | K951574 |
| 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