BEUDAMED
    FDA Enforcement Class II Terminated

    ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-1846-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1846-2021
    Event ID
    87984
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 16, 2021
    Initiation Date
    May 14, 2021
    Classification Date
    June 10, 2021
    Termination Date
    March 20, 2023
    Address
    Olof-palme-str. 9, N/A, Munich, N/A, N/A, Germany

    Description

    ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    Display of potential patient movement might be delayed to the user for high dose treatments.

    Code Info

    Version 1.02, GTIN 04056481142315

    Distribution

    US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.

    Quantity

    22 systems in the U.S.