FDA-Device2023-11-29Class II

Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-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
61 units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan
Products
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0339-2024

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