Gentuity, LLC — Class II recall: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

Summary

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… Status: Ongoing.

Entities

• Gentuity, LLC