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FDAApril 22, 2022device

Colonovideoscope Model CF-H180AL

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Terminated

Brands named

olympus

UPCs

04953170339615

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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