Gentuity HF-OCT Imaging System
Gentuity is recalling HF-OCT Imaging Systems running software versions 21.11–23.3.13 due to potential measurement inaccuracies.
Review the provided safety notification and follow the updated instructions for recognizing, avoiding, and mitigating repeated frames during imaging to ensure accurate measurements.
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.
How to identify it
UPC 00859910007032
Gentuity HF-OCT Imaging System Model G10-01;
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification