FDA-Device2019-03-20Class II
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Olympus Corporation of the Americas
Hazard
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Sold states
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Affected count
2
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2019Don't want to check this manually?
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