BEUDAMED
    FDA Recall Terminated

    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems

    Recall: Z-3211-2018 · Initiated August 31, 2018

    Recall

    Recall Number
    Z-3211-2018
    Event Number
    80933
    Firm
    Accuray Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 31, 2018
    Posted
    September 20, 2018
    Terminated
    December 16, 2020
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems

    Reason

    the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System

    Action

    The firm, Accuray, disseminated their "Urgent Field Safety Notices" dated 08/31/2018 by email and letter to its customers. The letter described the product, problem and actions to be taken. The letter requested the customers cease use and quarantine the product for recovery and replacement by an Accuray Representative and complete and return the Acknowledgement Form via email at: [email protected] or mail to: Accuray Incorporated, one Erdman place, Madison, WI 53719. If you have any questions, contact Vice President, Regulatory Affairs at 608-824-2800 or email: [email protected] or the Regulatory Affairs Specialist at 408-716-4660 or [email protected].

    Distribution

    Worldwide Distribution: United States (nationwide), and countries of: United Kingdom, Germany, France, Finland, Netherlands, Portugal, Hong Kong, Poland, Australia, United Arab Emirates, Thailand, and Japan.

    Quantity

    259 units