Gentuity, Llc: Gentuity Hf-oct Imaging System Model G10-01; Software Version 23.2.13

Gentuity HF-OCT Imaging System Recall Summary Gentuity is recalling the HF-OCT Imaging System Model G10-01 with software version 23.2.13 because the system may repeat frames during imaging pullback when used with certain catheters, which could affect the accuracy of length measurements. This issue affects medical facilities in the US (across most states), Belgium, and Japan that have this specific equipment and software version. The company is providing information to help users recognize and prevent this condition during use.

Recalling firm

Gentuity, LLC

Product

Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

Reason

The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.

Classification

Class II

Category

medical device recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-03-23

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Domestic - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX; International: United Arab Emirates, Belgium, Switzerland, Cyprus, Denmark, Spain, Finland, France, Greece, Italy, Japan, Kuwait, Latvia, Poland, Saudi Arabia, Slovakia;

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/d6eb84be-6425-4ef0-9554-48d2841dbdeb