FDA Device recall Z-0341-2024
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve)
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) by Aizu Olympus, citing channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the end….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0341-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-25 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aizu Olympus |
| Distribution | US |
Product
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.
Reason
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Identifiers
| code_info | Model Number (UDI-DI): PCF-H180AI (04953170339875), PCF-H180AL (04953170339899), PCF-H190DI (04953170363696), PCF-H190D…Model Number (UDI-DI): PCF-H180AI (04953170339875), PCF-H180AL (04953170339899), PCF-H190DI (04953170363696), PCF-H190DL (04953170363672), PCF-H190I (04953170305214), PCF-H190L (04953170305191), PCF-H190TI (04953170420719), PCF-H190TL (04953170420702), PCF-HQ190I (04953170416132), PCF-HQ190L (04953170416118), PCF-PH190I (04953170305252), PCF-PH190L (04953170305238), PCF-Q180AI (04953170307713), PCF-Q180AL (04953170307720), PCF-S (04953170339912). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0341-2024%22
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