medical Class II Updated 2023-11-29

Aizu Olympus Co., Ltd. recalls Signmoidovideoscope-For endoscopy and endoscopic surgery wit

Recalled Product

Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number (UDI-DI): PCF-S (04953170339912).
View official government recall

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