Recall Z-0181-2025— Olympus Corporation of the Americas

Name: FDA recall Z-0181-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-21

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-08-21. It names one FDA 510(k) clearance: K222584. Product: Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100. Reason: It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-08-21
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100Olympus Medical Systems Corporation·cleared 2023-04-26

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

Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Reason for recall

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

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