Skip to content
Recall Observatory FDA recall evidence

Device product

Insufflation unit, UHI-4.

Z-1375-2024

September 25, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 94080
Status
Ongoing
Classification
Class II
Quantity
3,172 Units
Official record key
device-enforcement:Z-1375-2024

Official wording

Reason: 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".

Code information: Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.

Distribution pattern: Domestic: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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".