BEUDAMED
    FDA Enforcement Class II Terminated

    MRIdian Linac Radiation Therapy System Model 10000 and 20000

    Recall: Z-0676-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0676-2020
    Event ID
    84303
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 18, 2019
    Initiation Date
    March 3, 2019
    Classification Date
    December 12, 2019
    Termination Date
    April 28, 2021
    Address
    815 E Middlefield Rd, N/A, Mountain View, CA, 94043-4025, United States

    Description

    MRIdian Linac Radiation Therapy System Model 10000 and 20000

    Reason

    Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

    Code Info

    Serial Numbers: 100, 101, 102, 103, 104, 105, 107, 108, 112, 113, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225 Device Listing Number: D158423 and D297999

    Distribution

    US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE

    Quantity

    24 Systems