BEUDAMED
    FDA Enforcement Class II Terminated

    Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

    Recall: Z-1109-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1109-2019
    Event ID
    82384
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 17, 2019
    Initiation Date
    March 12, 2019
    Classification Date
    April 8, 2019
    Termination Date
    November 3, 2023
    Address
    Linac House, Fleming Way, Crawley, N/A, N/A, United Kingdom

    Description

    Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

    Reason

    Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.

    Code Info

    Unity Systems: 13553-006/600003, 13371-002/600021, 10817-011/600010, 10562-011/600016, 10719-T03001/600013, 30004070-001/600023, 10420-AVL-U/600008, 11014-UMCU-U/600007, 10157-006/600014, 11611-40/600011, 30001461-J001/600002, 11489-21/600009,

    Distribution

    Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom

    Quantity

    12 units