Gentuity, LLC: Catheter, Intravascular, Diagnostic

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.

Tags

FDA recall, medical device, class 2, Cardiovascular, Device Design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security

Source record id

Z-1823-2026

First seen by InfoSec Signals

9/23/2026

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