BEUDAMED
    FDA Recall Open, Classified

    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

    Recall: Z-1823-2026 · Initiated March 23, 2026

    Recall

    Recall Number
    Z-1823-2026
    Event Number
    98619
    Firm
    Gentuity, LLC
    FEI Number
    3011578544
    Product Code
    DQO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 23, 2026
    Posted
    April 16, 2026
    Address
    142 North Rd, Ste G, Sudbury, MA, 01776-1142

    Description

    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

    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.

    Action

    On March 23, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: The customers will be required to follow the updated instructions to correct for repeated frames per the revised Operator Manual to address longitudinal measurement accuracy until the updated version of the software that addresses this issue is installed on the console within 6 months.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, GA, IL, MA, MN, NJ, NY, OH, PA, TX and the countries of Belgium, Japan.

    Quantity

    184 units (28 US, 156 OUS)