BEUDAMED
    FDA Recall Terminated

    MRIdian Linac Radiation Therapy System, Model 20000.

    Recall: Z-1251-2019 · Initiated March 18, 2019

    Recall

    Recall Number
    Z-1251-2019
    Event Number
    82612
    Firm
    Viewray, Inc.
    FEI Number
    3011233554
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 18, 2019
    Terminated
    June 16, 2022
    Address
    815 E Middlefield Rd, Mountain View, CA, 94043-4025

    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.

    Action

    An undated letter was issued via email to customers on 3/18/2019, except for one customer who was issued the letter on 3/26/2019.

    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