BEUDAMED
    FDA Enforcement Class II Ongoing

    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

    Recall: Z-1259-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1259-2023
    Event ID
    91664
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    February 14, 2023
    Classification Date
    March 16, 2023
    Address
    Olof-palme-str. 9, N/A, Munich, N/A, N/A, Germany

    Description

    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.

    Reason

    Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

    Code Info

    Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.

    Distribution

    US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution.

    Quantity

    56 systems in the U.S.