FDA-Device2023-11-29Class II
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
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
25 units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan
Products
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0344-2024Don't want to check this manually?
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