BEUDAMED
    FDA Recall Terminated

    Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.

    Recall: Z-1126-2013 · Initiated March 19, 2013

    Recall

    Recall Number
    Z-1126-2013
    Event Number
    64712
    Firm
    Accuray Incorporated
    FEI Number
    1000123585
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 19, 2013
    Posted
    April 16, 2013
    Terminated
    October 23, 2013
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.

    Reason

    A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.

    Action

    On 3/19/13, an "Urgent Device Correction Letter" was distributed to all affected users, with a description of the problem and user corrective action steps. US customers can contact 1-877- 668-8667 if questions.

    Distribution

    Worldwide distribution, including Nationwide in the US and the countries of Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan and Saudi Arabia.

    Quantity

    176 units