BEUDAMED
    FDA Enforcement Class II Terminated

    ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    Recall: Z-0481-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0481-2021
    Event ID
    86661
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viewray, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 2, 2020
    Initiation Date
    October 20, 2020
    Classification Date
    November 20, 2020
    Termination Date
    October 13, 2023
    Address
    815 E Middlefield Rd, N/A, Mountain View, CA, 94043-4025, United States

    Description

    ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    Reason

    There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

    Code Info

    All Lots/Serial Numbers

    Distribution

    Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.

    Quantity

    3 systems