BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    Recall: Z-3126-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3126-2024
    Event ID
    94928
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hitachi America, Ltd., Particle Therapy Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2024
    Initiation Date
    May 27, 2024
    Classification Date
    September 12, 2024
    Address
    2535 Augustine Dr, 2nd fl, Santa Clara, CA, 95054, United States

    Description

    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    Reason

    During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

    Code Info

    Lot Code: (01)04560333350006(21)CRUS01(11)190920

    Distribution

    U.S. Nationwide distribution in the states of TN, TX, and WA.

    Quantity

    1