Gentuity, LLC — Class II: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Gentuity, LLC is addressing a software issue in the Gentuity HF-OCT Imaging System (Model G10-01) where repeated frames may occur during pullbacks when using specific software versions (21.11 to 23.3.13) with Vis-Rx and Vis-Rx Prime catheters. This correction provides instructions for users to recognize and mitigate the condition to ensure accurate longitudinal measurements.
The recall affects Gentuity, LLC and clinical facilities utilizing the HF-OCT Console with software versions 21.11 through 23.3.13, specifically staff performing and interpreting OCT imaging with Vis-Rx and Vis-Rx Prime catheters.
Software-driven measurement errors in diagnostic imaging systems can lead to clinical inaccuracies during interventional procedures. This recall underscores the importance of software validation and the need for robust user notification when technical anomalies impact device output. The ongoing status suggests that mitigation strategies and potentially software updates are still being disseminated across the installed base.
Clinical users should be trained to identify repeated frames during HF-OCT pullbacks to avoid measurement inaccuracies. QA and Regulatory teams must ensure that correction notifications reach all facilities using software versions 21.11 through 23.3.13 and confirm receipt of mitigation instructions.
Class II. Reason: 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.. Product: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;. Firm: Gentuity, LLC (Sudbury MA United States). Status: Ongoing.
Open in openFDA / FDA.gov