Z-1375-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2024
- Initiation Date
- September 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,172 Units
Product Description
Insufflation unit, UHI-4.
Reason for Recall
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".
Distribution Pattern
Domestic: Nationwide Distribution.
Code Information
Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.