FDA-Device2024-04-03Class II
Insufflation unit, UHI-4.
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-1375-2024More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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