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Olympus Corporation of the Americas recalls Colonovideoscope Model CF-H180AL
Recalled June 29, 2022 · FDA recall Z-1274-2022 · 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 · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of KY.
Description
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
Product
Colonovideoscope Model CF-H180AL
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →