BEUDAMED
    FDA Recall Terminated

    HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.

    Recall: Z-0473-2011 · Initiated May 28, 2010

    Recall

    Recall Number
    Z-0473-2011
    Event Number
    55682
    Firm
    Philips Medical Systems
    FEI Number
    1000524572
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 28, 2010
    Posted
    November 26, 2010
    Terminated
    September 13, 2013
    Address
    2301 5th Ave, Ste 200, Seattle, WA, 98121

    Description

    HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.

    Reason

    Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable.

    Action

    Philips Medical Systems issued an Urgent Medical Device Recall letter dated May 28, 2010 identifying the affected device and actions to be taken. Customers were instructed to review their inventory for affected devices. If affected devices are found, the customer should contact Philips to arrange for a replacement device. The customer should also run a battery insertion test. If the device passes the test, the AED may remain in service until a replacement is received. For further information, contact Philips at 1 800 263-3342, option 6.

    Distribution

    Worldwide Distribution: Throughout the USA, and to the following countries: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIETNAM.

    Quantity

    1,478 units