medical Class II Updated 2024-11-27

Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1

Recalled Product

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, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.
View official government recall

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