Device recall
Z-0636-2017: Pentax Video Colonoscope is intended to be used with a PENTAX video processor…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-0636-2017 |
|---|---|
| Recall event | 75306 |
| Product | Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the… |
| Product code | FDF |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2018 |
| 510(k) numbers | K131855 |
| 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