FDA recall Z-1274-2022

Olympus Corporation of the Americas · Class II · device

Product

Colonovideoscope Model CF-H180AL

Reason for recall

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

Distribution

US Nationwide distribution in the state of KY.

Key facts

Status: Terminated
Initiation date: 2022-04-22
Report date: 2022-06-29
Termination date: 2024-03-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1274-2022