BEUDAMED
    FDA Recall Terminated

    The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

    Recall: Z-3185-2011 · Initiated April 14, 2010

    Recall

    Recall Number
    Z-3185-2011
    Event Number
    55319
    Firm
    Spacelabs Healthcare, Incorporated
    FEI Number
    3010157426
    Product Code
    MHZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 14, 2010
    Posted
    September 12, 2011
    Terminated
    September 12, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

    Reason

    There have been reports that the Spacelabs Medical Vital Signs Monitor, Model 91220, will not power up with AC power and will no longer charge the batteries.

    Action

    SpaceLabs Healthcare sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 15, 2010, to all affected customers. International consignees were notified by e-mail on April 22, 2010, with the customer notification letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use the device until their monitors can be upgraded. Customers were asked to brief their staff about the possibility of the monitor failure to help prevent an adverse event from happening.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of UNITED ARAB EMIRATES, ARGENTINA, AUSTRALIA, BELGIUM, BAHRAIN, BRAZIL, CANADA, CHINA, COLOMBIA, GERMANY, ECUADOR, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, JORDAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, MALAYSIA, OMAN, POLAND, PUERTO RICO, PARAGUAY, ROMANIA, SAUDI ARABIA, SINGAPORE, SYRIAN ARAB REPUBLIC, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and URUGUAY.

    Quantity

    614 units