BEUDAMED
    FDA Recall Terminated

    Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is 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-1862-2008 · Initiated May 1, 2008

    Recall

    Recall Number
    Z-1862-2008
    Event Number
    48164
    Firm
    Accuray Inc
    FEI Number
    1000123585
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 1, 2008
    Posted
    September 16, 2008
    Terminated
    November 30, 2010
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is 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

    Couch may move unexpectedly, which may result in patient impacting the linear accelerator.

    Action

    All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted. Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or [email protected] for additional information.

    Distribution

    Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.

    Quantity

    105 units