Device recall
Z-0084-2014: PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I…
FDA device recall · Class I · Pentax Medical Company
Key facts
| Recall number (Z-number) | Z-0084-2014 |
|---|---|
| Recall event | 66379 |
| Product | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation. |
| Product code | FCX |
| Recalling firm | Pentax Medical Company |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 9, 2014 |
| 510(k) numbers | K850020 |
| FEI number | 1000080301 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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