BEUDAMED
    FDA Enforcement Class II Terminated

    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.

    Recall: Z-1846-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1846-2014
    Event ID
    68384
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    May 9, 2014
    Classification Date
    June 20, 2014
    Termination Date
    November 12, 2014
    Address
    FRIEDRICH-EBERT-STR. 1, N/A, BERGISCH GLADBACH, N/A, N/A, Germany

    Description

    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.

    Reason

    Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.

    Code Info

    Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.

    Distribution

    US Distribution in tthe state of CA

    Quantity

    1