medical Class II Updated 2023-11-29

Aizu Olympus Co., Ltd. recalls Gastroscope-endoscopic ultrasound (EUS) guided fine needle a

Recalled Product

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, GF-UE160-AL5.


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 Numbers: GF-UC140P-AL5 (04953170356322), GF-UCT180 (04953170356339), GF-UE160-AL5 (04953170356261).
View official government recall

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