FDA-Device2024-10-30Class II
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Olympus Corporation of the Americas
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-0181-2025Don't want to check this manually?
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