BEUDAMED
    FDA Recall Terminated

    Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.

    Recall: Z-3024-2011 · Initiated September 23, 2010

    Recall

    Recall Number
    Z-3024-2011
    Event Number
    56839
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 23, 2010
    Posted
    August 15, 2011
    Terminated
    August 17, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive blood pressures; invasive blood pressures; body temperature; functional arterial oxygen saturation; and entidal CO2.

    Reason

    The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU.

    Action

    Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to all affected customers. The letter describes the product, problem, and the action to be taken. The letter includes the revised Operator's Manual as a replacement for customers current manual. For Technical Support call Spacelabs Medical at 1-800-522-7025 and select 2.

    Distribution

    Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, KENYA, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MACEDONIA, MALAYSIA, NEPAL, NETHERLANDS, NICARAGUA, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU, PUERTO RICO, PHILIPPINES, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.

    Quantity

    2517