Home / Recalls / Olympus Corporation of the Americas / Z-0498-2025

Z-0498-2025 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
November 27, 2024
Initiation Date
September 18, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1749 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Domestic: US Nationwide Distribution.

Code Information

Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.

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