Olympus Corporation of the Americas: Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product D

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.

Details from the source

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: Domestic: US Nationwide Distribution. Quantity: 1749 units Lot/code info: Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.

UPC codes

04953170343360

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.