FDAFDA · Food and drugs·Recall number Z-0342-2024
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Published November 29, 2023 · Recall initiated: September 25, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aizu Olympus Co., Ltd.
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- Model Number (UDI-DI): PCF-S (04953170339912).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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