BEUDAMED
    FDA Enforcement Class II Terminated

    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    Recall: Z-0524-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0524-2014
    Event ID
    66992
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE OEC Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    November 26, 2013
    Classification Date
    December 17, 2013
    Termination Date
    April 17, 2017
    Address
    384 Wright Brothers Dr, N/A, Salt Lake City, UT, 84116-2862, United States

    Description

    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

    Reason

    GE OEC Medical Systems Inc is recalling InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.

    Code Info

    Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus

    Distribution

    Nationwide Distribution

    Quantity

    654