medical Class II Updated 2024-12-11

Olympus Corporation of the Americas recalls EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model

Recalled Product

EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

Hazard / Issue

High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
View official government recall

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