Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Recall date
August 21, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0181-2025
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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