FDA-Device2022-06-29Class II
Colonovideoscope Model CF-H180AL
Olympus Corporation of the Americas
Hazard
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
Sold states
US Nationwide distribution in the state of KY.
Affected count
1 unit
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Colonovideoscope Model CF-H180AL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1274-2022Don't want to check this manually?
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