FDA Enforcement
Class II
Ongoing
Insufflation unit, UHI-4.
Recall: Z-1375-2024
·
Reported April 3, 2024
Enforcement
- Recall Number
- Z-1375-2024
- Event ID
- 94080
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 3, 2024
- Initiation Date
- September 25, 2023
- Classification Date
- March 25, 2024
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
Insufflation unit, UHI-4.
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 Info
Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.
Distribution
Domestic: Nationwide Distribution.
Quantity
3,172 Units