BEUDAMED
    FDA Enforcement Class II 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 · Reported May 1, 2013

    Enforcement

    Recall Number
    Z-1155-2013
    Event ID
    64809
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accuray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2013
    Initiation Date
    March 27, 2013
    Classification Date
    April 19, 2013
    Termination Date
    August 20, 2013
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100, United States

    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.

    Code Info

    Model number: 025007

    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.