Device recall
Z-2080-2016: Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not…
FDA device recall · Class II · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-2080-2016 |
|---|---|
| Recall event | 73894 |
| Product | Small Bowel Scope 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 indications consistent with the need for procedure are observed in adult and pediatric… |
| Product code | FGB |
| Recalling firm | Pentax Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2017 |
| FEI number | 1000080301 |
At a glance
- None Linked 510(k)s
- 10–99 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