BEUDAMED
    FDA Recall Terminated

    GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.

    Recall: Z-1488-2014 · Initiated March 27, 2014

    Recall

    Recall Number
    Z-1488-2014
    Event Number
    67905
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 27, 2014
    Posted
    April 23, 2014
    Terminated
    January 14, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.

    Reason

    GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.

    Action

    GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 27, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Managers of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare service representative).

    Distribution

    USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI. OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, INDIA,IRELAND, ITALY, JAPAN, KOREA, NETHERLAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN.

    Quantity

    447 (81US, 366 OUS)