Recall Z-1274-2022— Olympus Corporation of the Americas

Name: FDA recall Z-1274-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-22

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-04-22, terminated 2024-03-13. It names one FDA 510(k) clearance: K100584. Product: Colonovideoscope Model CF-H180AL. Reason: 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.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2022-04-22
Terminated: 2024-03-13
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K100584 — EVIS EXERAII 180 SYSTEMOlympus Medical Systems Corporation·cleared 2010-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.