FDA-Device2023-11-15Class II
EVIS EXERA III Gastrointestinal Videoscope
Olympus Corporation of the Americas
Hazard
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Sold states
Nationwide Distribution.
Affected count
1687 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA III Gastrointestinal Videoscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2024Don't want to check this manually?
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