BEUDAMED
    FDA Recall Terminated

    CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-0714-2011 · Initiated October 28, 2010

    Recall

    Recall Number
    Z-0714-2011
    Event Number
    57236
    Firm
    Accuray Inc
    FEI Number
    1000123585
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 28, 2010
    Posted
    December 16, 2010
    Terminated
    April 1, 2011
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.

    Action

    Accuray Inc., sent an "URGENT DEVICE CORRECTION" letter dated October 21, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to increase the size of the dose box to include CT volume, not just the contoured anatomy; recalculate dose at high resolution, and examine the treatment plan to ensure that applicable organs at risk are accounted for and all portions of the patient receive the desired level of doses. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA), +1-408-716-4700 (non-USA) or email: [email protected].

    Distribution

    USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela.

    Quantity

    219 units