BEUDAMED
    FDA Enforcement Class II Terminated

    Easy Diagnost Eleva Universal Fluoroscopic applications

    Recall: Z-0431-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0431-2014
    Event ID
    66705
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2013
    Initiation Date
    October 30, 2013
    Classification Date
    December 2, 2013
    Termination Date
    January 9, 2017
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Easy Diagnost Eleva Universal Fluoroscopic applications

    Reason

    The delivered application software was an outdated version to the model of equipment.

    Code Info

    706050, 706083, 706088

    Distribution

    Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.

    Quantity

    19 devices