FDA-Device2024-03-06Class II
Colonoscope, Model Number PCF-HQ190L.
Hazard
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Sold states
US Nationwide distribution.
Affected count
28
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Colonoscope, Model Number PCF-HQ190L.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1213-2024More 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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