BEUDAMED
    FDA Enforcement Class II Ongoing

    mint Lesion, Software Versions: 3.10.0 and 3.10.1.

    Recall: Z-0710-2025 · Reported December 25, 2024

    Enforcement

    Recall Number
    Z-0710-2025
    Event ID
    95880
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mint Medical GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 25, 2024
    Initiation Date
    November 15, 2024
    Classification Date
    December 19, 2024
    Address
    Friedrich-Ebert-Str. 2, Dossenheim, N/A, Germany

    Description

    mint Lesion, Software Versions: 3.10.0 and 3.10.1.

    Reason

    Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

    Code Info

    Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;

    Distribution

    Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.

    Quantity

    18 units (7 US, 11 OUS)