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Gentuity, LLC recalls Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Recalled April 22, 2026 · FDA recall Z-1823-2026 · Gentuity
Hazard
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. · FDA Class II
Units
184 units (28 US, 156 OUS)
Sold at
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;
Description
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.
Product
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Manufacturer(s)
Gentuity, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →