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

Recall date

March 23, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1823-2026

FDA classification

Class II

Brand / firm

Gentuity, LLC

Sold / distributed

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;

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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