Aizu Olympus Co., Ltd.: Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180

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: 680 units Lot/code info: Model Numbers: GF-UC140P-AL5 (04953170356322), GF-UCT180 (04953170356339), GF-UE160-AL5 (04953170356261).

UPC codes

04953170356322, 04953170356339, 04953170356261

Source

Official record: FDA (Device enforcement) ↗

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