BEUDAMED
    FDA Enforcement Class II 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 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1126-2013
    Event ID
    64712
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accuray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 19, 2013
    Classification Date
    April 16, 2013
    Termination Date
    October 23, 2013
    Address
    1310 Chesapeake Ter, N/A, Sunnyvale, CA, 94089-1100, United States

    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.

    Code Info

    All units of these models.

    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