FDA-Device2024-10-30Class II
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Hazard
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
Sold states
US Nationwide distribution.
Affected count
1407 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0181-2025More 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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