BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1142-2013 · Initiated October 21, 2011

    Recall

    Recall Number
    Z-1142-2013
    Event Number
    64884
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    October 21, 2011
    Posted
    April 18, 2013
    Terminated
    February 4, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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

    Action

    A field action was initiated on October 21, 2011, and completed March 9, 2012, . The issue was corrected to all affected systems by applying the missing label onto the gantry. No recall letter was issued. For further questions please call (262) 513-4122.

    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