Device recall
Z-0329-2024: Colonoscope: for endoscopy and endoscopic surgery within the lower digestive…
FDA device recall · Class II · Aizu Olympus Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0329-2024 |
|---|---|
| Recall event | 93222 |
| Product | Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L… |
| Product code | FET |
| Recalling firm | Aizu Olympus Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K001241, K051645, K100584, K111756, K112680, K954451 |
| FEI number | 3002964398 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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