BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only.

    Recall: Z-1558-2009 · Initiated May 8, 2009

    Recall

    Recall Number
    Z-1558-2009
    Event Number
    52019
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 8, 2009
    Posted
    September 4, 2009
    Terminated
    February 4, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only.

    Reason

    GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) an

    Action

    An "Urgent Medical Device Correction" letter was issued to consignees on or about April 9, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A representative from GE Healthcare will contact customers to schedule implementation of the correction when it is available for installation at the customer's facility. Direct questions regarding this notice to GE Healthcare Technical Support or your local GE Distributor and refer to FMI 36042.

    Distribution

    Worldwide Distribution -- US (including DC and states of AL, AK, AZ, AR, CA, CO, FL, IL, IN, IA, KS, KY, LA, ME, MD, MI,MN, MO,MT, NE, NH, NJ, NY, NC, OH, OK OR, PA, SC, TX, UT,VT, VA, WA, WV and WI) and countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, CYPRUS, DENMARK, ESTONIA, FRANCE, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, PORTUGAL SAUDI ARABIA, SERBIA, SOUTH AFRICA, SWEDEN SWITZERLAND, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES and UNITED KINGDOM.

    Quantity

    2,638