BEUDAMED
    FDA Enforcement Class II 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 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3211-2018
    Event ID
    80933
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accuray Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 26, 2018
    Initiation Date
    August 31, 2018
    Classification Date
    September 20, 2018
    Termination Date
    December 16, 2020
    Address
    1240 Deming Way, N/A, Madison, WI, 53717-1954, United States

    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

    Code Info

    All units with the Ashland Brand distributed between August 1, 2017 and July 31, 2018

    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