FDAFDA · Food and drugs·Recall number Z-1375-2024
Insufflation unit, UHI-4.
Published April 3, 2024 · Recall initiated: September 25, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Domestic: Nationwide Distribution.
- Lot
- Model and serial number: UHI-4: UDI/DI: 04953170324147; All serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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