Company: Gentuity, LLC
Date of Enforcement Report: 4/16/2026
Class: II

PRODUCT:

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

Recall Number:

Z-1823-2026

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.

RECALLING FIRM/MANUFACTURER:

Gentuity, LLC

VOLUME:

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;