—#193842

Product

Colonovideoscope Model CF-H180AL

FDA product code: FDF — Colonoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K100584
Affected lot / code info: UDI-DI: 04953170339615 Serial number: 2501131

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 Cynthia.Ow@Olympus.com

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution in the state of KY.

Timeline

Recall initiated: 2022-04-22
Terminated: 2024-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193842. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.