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.
Enforcement
- Recall Number
- Z-0341-2024
- Event ID
- 93222
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aizu Olympus Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- September 25, 2023
- Classification Date
- November 17, 2023
- Address
- 3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, N/A, Japan
Description
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.
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
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).
Worldwide - US Nationwide distribution.
3101 units