BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Definium 5000 / 5220493 X-Ray System

    Recall: Z-0703-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0703-2013
    Event ID
    64134
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    September 26, 2012
    Classification Date
    February 27, 2013
    Termination Date
    December 5, 2013
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Definium 5000 / 5220493 X-Ray System

    Reason

    When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.

    Code Info

    Definium Model 5000/5220493

    Distribution

    Nationwide Distribution

    Quantity

    312 installed in US