# FDA recall Z-0341-2024

> **Aizu Olympus Co., Ltd.** · Class II · device recall initiated 2023-09-25.

## 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 for recall

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

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0341-2024
- **Recalling firm:** Aizu Olympus Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-25
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aizuwakamatsu, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0341-2024

## Citation

> AI Analytics. FDA recall Z-0341-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0341-2024. Source: US FDA. Licensed CC0.

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