BEUDAMED
    FDA Recall Terminated

    LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.

    Recall: Z-1903-2010 · Initiated May 27, 2010

    Recall

    Recall Number
    Z-1903-2010
    Event Number
    55853
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 27, 2010
    Posted
    July 1, 2010
    Terminated
    October 21, 2014
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.

    Reason

    A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate.

    Action

    Firm began mailing Urgent Medical Device Correction notifications to affected customers on May 26, 2010 regarding the power supply to the device. All affected power supplies will be updated; this will be accomplished in two phases. Devices at a higher risk will be updated first in phase 1. The remaining lower risk devices will be updated afterward in Phase 2. Customers are advised to keep the defibrillators in service, and to follow recommended daily Operator Checklist steps, while service updates are scheduled. Customers with questions should contact the firm at 800-442-1142 between 6 am and 4 pm Pacific Time, Monday - Friday

    Distribution

    Worldwide distribution. In US, distributed domestically including to gov't accounts; and internationally to the following countries: ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PUERTO RICO, SAUDI ARABIA, SOUTH AFRICA, SYRIA, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS, and YEMEN.

    Quantity

    43,001 units