BEUDAMED
    FDA Enforcement Class II Terminated

    ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.

    Recall: Z-1836-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1836-2021
    Event ID
    87865
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 16, 2021
    Initiation Date
    May 4, 2021
    Classification Date
    June 9, 2021
    Termination Date
    October 19, 2023
    Address
    815 E Middlefield Rd, N/A, Mountain View, CA, 94043-4025, United States

    Description

    ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.

    Reason

    Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

    Code Info

    French version of the TDS software affected serial numbers: 214, 215, 226 and 240 German or Italian versions of the TDS software affected serial numbers: 203, 232, 108 and 244

    Distribution

    International distribution only to the countries of France, Germany, Italy, and Switzerland.

    Quantity

    8 versions