BEUDAMED
    FDA Enforcement Class II Ongoing

    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

    Recall: Z-0733-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0733-2022
    Event ID
    89662
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Brainlab AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 16, 2022
    Initiation Date
    February 25, 2022
    Classification Date
    March 8, 2022
    Address
    Olof-palme-str. 9, N/A, Munich, N/A, N/A, Germany

    Description

    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

    Reason

    The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.

    Code Info

    Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315.

    Distribution

    Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, New Zealand, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey, United Kingdom, and United Arab Emirates.

    Quantity

    205 systems