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FDA device recallVulnerabilitiesPublished Apr 16, 2026
Gentuity, LLC: Catheter, Intravascular, Diagnostic
Updated 2 hours ago ()
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
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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