BEUDAMED
    FDA Enforcement Class II Terminated

    Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.

    Recall: Z-2289-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2289-2020
    Event ID
    85651
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2020
    Initiation Date
    April 30, 2020
    Classification Date
    June 5, 2020
    Termination Date
    August 4, 2021
    Address
    400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States

    Description

    Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.

    Reason

    potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.

    Code Info

    Serial numbers 600001 - 600043

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX, and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, UK.

    Quantity

    32 units