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Gentuity Recalls
1 recall on record · April 22, 2026 to April 22, 2026 · Medical Devices
April 22, 2026
Medical Devices
FDA
Gentuity, LLC recalls Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
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.
Gentuity Recalls | RecallWatchUSA