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FDASeptember 18, 2024device

Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170343360

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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