Z-1274-2022 Class II Terminated
FDA device recall Z-1274-2022 was initiated by Olympus Corporation Of The Americas on Apr 22, 2022 and is designated Class II. 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… The recall status is terminated (terminated Mar 13, 2024). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 29, 2022
- Initiation Date
- Apr 22, 2022
- Termination Date
- Mar 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1274-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026