BEUDAMED
    FDA Recall Terminated

    Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.

    Recall: Z-0828-2014 · Initiated January 13, 2014

    Recall

    Recall Number
    Z-0828-2014
    Event Number
    67278
    Firm
    Accuray Incorporated
    FEI Number
    1000123585
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 13, 2014
    Posted
    January 27, 2014
    Terminated
    November 25, 2014
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.

    Reason

    Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.

    Action

    Urgent Medical Device Correction notification letter were sent out beginning January 14, 2014 by trackable method. Letters describe potential problem and provide inspection instructions to be performed prior to use.

    Distribution

    Worldwide Distribution. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Colombia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam

    Quantity

    302 devices; 149 in US, 153 out of US.