Device recall
Z-2449-2021: Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-2449-2021 |
|---|---|
| Recall event | 88440 |
| Product | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and… |
| Product code | FDF |
| Recalling firm | Pentax of America Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K131855, K181084, K210485 |
| 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