BEUDAMED
    FDA Recall Terminated

    MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-0115-2016 · Initiated August 27, 2015

    Recall

    Recall Number
    Z-0115-2016
    Event Number
    72166
    Firm
    Viewray Incorporated
    FEI Number
    3007546534
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 27, 2015
    Posted
    October 9, 2015
    Terminated
    June 9, 2017
    Address
    2 Thermo Fisher Way, Oakwood Village, OH, 44146-6536

    Description

    MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

    Action

    ViewRay sent an Customer Advisory Notice dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It is recommended that if you have a patient on the couch and you receive the fault ''The patient table has experienced an unintended movement. This may be due to the patient or operator leaning on the table. Clear the fault and retry. If the problem persists call Service" on the TPDS,first attempt to clear the fault. If it does not clear and requires you to restart the couch software (same switch as restarting the RTCS) you should manually remove the patient from the couch before restarting the system. A software patch to address this issue is planned for early 2016. In the meantime please practice our recommendation of removing the patient from the couch prior to restarting the RTCS. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at [email protected] or call the ViewRay Customer Support center at 855-286-8875.

    Distribution

    US Distribution to the states of : CA, MO and WI., and Internationally to Korea.

    Quantity

    4 units