BEUDAMED
    FDA Recall Terminated

    RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

    Recall: Z-1155-2013 · Initiated March 27, 2013

    Recall

    Recall Number
    Z-1155-2013
    Event Number
    64809
    Firm
    Accuray Incorporated
    FEI Number
    1000123585
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 27, 2013
    Posted
    April 20, 2013
    Terminated
    August 20, 2013
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.

    Reason

    A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.

    Action

    Accuray issued an Urgent Advisory Notification letter dated March 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Field Service Engineers will be replacing the affected product. Questions and concerns are to be directed to Accuray Customer Support at 1-877-668-8667

    Distribution

    Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.

    Quantity

    16 devices are subject to correction.