BEUDAMED
    FDA Recall Terminated

    Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: GE. Product name: Responder. Device Operation: Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes.

    Recall: Z-1248-2010 · Initiated February 3, 2010

    Recall

    Recall Number
    Z-1248-2010
    Event Number
    54517
    Firm
    Cardiac Science Corporation
    FEI Number
    2112020
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 3, 2010
    Posted
    April 6, 2010
    Terminated
    December 8, 2011
    Address
    3303 Monte Villa Pkwy, Bothell, WA, 98021-8969

    Description

    Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: GE. Product name: Responder. Device Operation: Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes.

    Reason

    A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.

    Action

    The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. [email protected] to arrange for replacement(s).

    Distribution

    Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.

    Quantity

    1