BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.

    Recall: Z-1994-2009 · Initiated February 6, 2006

    Recall

    Recall Number
    Z-1994-2009
    Event Number
    51278
    Firm
    GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226
    FEI Number
    3005860720
    Product Code
    MLD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 6, 2006
    Posted
    September 1, 2009
    Terminated
    May 17, 2012

    Description

    Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.

    Reason

    GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result i

    Action

    GE Healthcare Technologies issued a Marketing Bulletin "Ref: MB MS HKI 06007" dated February 6, 2006 to explain a software update.

    Distribution

    ITALY, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRAN, ISRAEL JORDAN, LITHUANIA, ITALY, MACEDONIA, MALAYSIA, MEXICO, NETHERLAND, NICARAGUA, NORWAY, POLAND, PORTUGAL PUERTO RICO, RUSSIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SWEDEN, SYRIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA.

    Quantity

    873