BEUDAMED
    FDA Enforcement Class II Terminated

    MRIdian Linac Radiation Therapy System, Model 20000.

    Recall: Z-1251-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1251-2019
    Event ID
    82612
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    March 18, 2019
    Classification Date
    May 2, 2019
    Termination Date
    June 16, 2022
    Address
    815 E Middlefield Rd, N/A, Mountain View, CA, 94043-4025, United States

    Description

    MRIdian Linac Radiation Therapy System, Model 20000.

    Reason

    A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

    Code Info

    Serial Numbers 101,107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.

    Distribution

    Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,

    Quantity

    17 devices