FDA recall Z-0181-2025

Olympus Corporation of the Americas · Class II · device

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-08-21
Report date: 2024-10-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0181-2025