BEUDAMED
    FDA Enforcement Class II Terminated

    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

    Recall: Z-1185-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1185-2021
    Event ID
    87395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 17, 2021
    Initiation Date
    March 1, 2021
    Classification Date
    March 8, 2021
    Termination Date
    March 20, 2023
    Address
    Olof-palme-str. 9, Munich, N/A, Germany

    Description

    ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

    Reason

    In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.

    Code Info

    Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2.

    Distribution

    USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.

    Quantity

    73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed