FDA-Device2023-11-29Class II
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.
Aizu Olympus Co., Ltd.
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
Sold states
Worldwide - US Nationwide distribution.
Affected count
680 units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0333-2024Don't want to check this manually?
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