Colonovideoscope Model CF-H180AL
FDA Recall Z-1274-2022 · Posted None
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Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeFDF
Date Initiated2022-04-22
Date Terminated2024-03-13
Product Quantity1 unit
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
Firm Action
Olympus issued letter via e-mail on April 22, 2022. Letter states reason for recall, health risk and action to take:
1. Identify the affected model and serial number in the subject of this letter.
2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge.
3. Olympus will provide a service loaner device in an effort to not disrupt patient care.
Contact: 647-999-3203 or at [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the state of KY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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