Recall Z-1213-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1213-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-11

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-01-11. It names one FDA 510(k) clearance: K192793. Product: Colonoscope, Model Number PCF-HQ190L.. Reason: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-01-11
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K192793 — Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190IOlympus Medical Systems Corp.·cleared 2020-07-17

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

Colonoscope, Model Number PCF-HQ190L.

Reason for recall

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

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