FDA-Device2022-06-29Class II
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Olympus Corporation of the Americas
Hazard
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
Sold states
US Nationwide distribution in the states of AL, FL, NC, NY.
Affected count
8 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1275-2022Don't want to check this manually?
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