BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.

    Recall: Z-1142-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1142-2013
    Event ID
    64884
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 24, 2013
    Initiation Date
    October 21, 2011
    Classification Date
    April 18, 2013
    Termination Date
    February 4, 2014
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.

    Reason

    As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co

    Code Info

    Serial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7

    Distribution

    Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.

    Quantity

    48