BEUDAMED
    FDA Recall Terminated

    RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA The CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The RoboCouch Patient Support System 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-0856-2009 · Initiated October 30, 2008

    Recall

    Recall Number
    Z-0856-2009
    Event Number
    50208
    Firm
    Accuray Inc
    FEI Number
    1000123585
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 30, 2008
    Posted
    January 14, 2009
    Terminated
    September 10, 2009
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089

    Description

    RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA The CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The RoboCouch Patient Support System 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

    Product may not be tensioned properly, potentially causing unexpected rotation or descent.

    Action

    All affected sites were notified of the potential problem via Customer Advisory Notice dated 30 October 2008. The letter states required actions that the customer should follow at the beginning of each treatment day. The tension of the belt drive and the support bolts in question will be inspected by Accuray Field Service personnel at the affected facilities. In addition, the preventive maintenance procedure will be updated to include regular inspection and replacement of the belt-drive. Any questions or concerns regarding this issue should be directed to Accuray Customer Support at 1-877-668-8667 or 1-408-716-4700 or [email protected].

    Distribution

    Worldwide Distribution --- including USA and countries of France and Turkey.

    Quantity

    13 units