Z-0342-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: 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 Pattern
Worldwide - US Nationwide distribution.
Code Information
Model Number (UDI-DI): PCF-S (04953170339912).