BEUDAMED
    FDA Recall Terminated

    ViewRay MRIdian Linac System: Model No. 20000, 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-0482-2021 · Initiated October 20, 2020

    Recall

    Recall Number
    Z-0482-2021
    Event Number
    86661
    Firm
    Viewray, Inc.
    FEI Number
    3011233554
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 20, 2020
    Terminated
    October 13, 2023
    Address
    815 E Middlefield Rd, Mountain View, CA, 94043-4025

    Description

    ViewRay MRIdian Linac System: Model No. 20000, 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.

    Action

    On 10/20/2020, the firm, ViewRay, Inc, emailed an "Urgent Device Correction" notification to all affected consignees. In addition to informing consignees about the correction, the firm asked consignees to take the following actions.: 1. For Customer using TPDS software ver. 5.2.5 or earlier with optional 3 Plane imaging: - Do: Maintain a distance of at least 5 cm (~2) between the receive coil and the inner surface of the bore wall when using 3 Plane cin treatment imaging (Figure 3 & 4). - Do Not: Select 3 Plane cin treatment imaging if a distance of at least 5 cm (~2) cannot be maintained between the receive coil and the inner surface of the bore wall during treatment. 2. For Customer Using TPDS software ver. 5.3 or later with optional 8 fps enabled: - Do Not: Use 8 fps cin treatment imaging until further guidance is provided by ViewRay. - Do: Use 4 fps cin treatment imaging when treating a patient. 3. If you have any questions related to this letter, please contact ViewRay Customer Support at [email protected] or call +1 855-286-8875.

    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

    35 units