BEUDAMED
    FDA Enforcement Class II Ongoing

    3mensio Workstation (Vascular Fenestrated) software

    Recall: Z-2297-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2297-2025
    Event ID
    97307
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PIE Medical Imaging B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    July 14, 2025
    Classification Date
    August 12, 2025
    Address
    Demertdwarsstraat 8A01, N/A, Maastricht, N/A, N/A, Netherlands

    Description

    3mensio Workstation (Vascular Fenestrated) software

    Reason

    When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage

    Code Info

    Software Version/UDI/Software Release Date: 10.6/(01)08056304455505(11)240325(8012)10.6/05-Apr-24, 10.7/(01)08056304455925(11)250423(8012)10.7/29-Apr-25, Service Packs/UDI: 10.6 SP1/(01)08056304455505(11)240411(8012)10.6 SP1/23-Apr-24, 10.6 SP2/(01)08056304455505(11)240610(8012)10.6 SP2/17-Jun-24, 10.6 SP3/(01)08056304455505(11)240926(8012)10.6 SP3/03-Oct-24, 10.6 SP4/(01)08056304455505(11)250109(8012)10.6 SP4/20-Jan-25, 10.7 SP1/(01)08056304455925(11)250523(8012)10.7 SP1/28-May-25

    Distribution

    US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.

    Quantity

    501