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

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

Details from the source

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. Quantity: 8 units Lot/code info: Model Number (UDI-DI): PCF-S (04953170339912).

UPC codes

04953170339912

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.