FDA-Device2024-04-03Class II

Insufflation unit, UHI-4.

Olympus Corporation of the Americas
Hazard

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

Sold states
Domestic: Nationwide Distribution.
Affected count
3,172 Units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Insufflation unit, UHI-4.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2024

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