BEUDAMED
    FDA Enforcement Class II Ongoing

    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

    Recall: Z-1392-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1392-2025
    Event ID
    96241
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2025
    Initiation Date
    February 10, 2025
    Classification Date
    March 18, 2025
    Address
    Olof-Palme-Str. 9, N/A, Munich, N/A, N/A, Germany

    Description

    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

    Reason

    Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

    Code Info

    Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    N/A