Device recall
Z-2448-2021: Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument…
FDA device recall · Class II · Pentax of America Inc
Key facts
| Recall number (Z-number) | Z-2448-2021 |
|---|---|
| Recall event | 88440 |
| Product | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels… |
| 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