Z-1274-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 29, 2022
- Initiation Date
- April 22, 2022
- Termination Date
- March 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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 Pattern
US Nationwide distribution in the state of KY.
Code Information
UDI-DI: 04953170339615 Serial number: 2501131