BEUDAMED
    FDA Enforcement Class II Terminated

    Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC

    Recall: Z-1110-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1110-2014
    Event ID
    67427
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    February 4, 2014
    Classification Date
    February 26, 2014
    Termination Date
    September 3, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC

    Reason

    HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers

    Code Info

    MRx devices and serial numbers within the following ranges: M3535A Serial Numbers: USD0100104 - USD0572207; M3536A Serial Numbers: USD0100902 - USD0543688; M3536J Serial Numbers USD0209838 - USD0332675; M3536M Serial Numbers: USD0500002 - USD0500009; M3536MC Serial Nukmbers: USD0500002 - USD0500028

    Distribution

    Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND France GERMANY GHANA GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS¿ LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MONGOLIA MOROCCO MOZAMBIQUE MYANMAR (Burma)¿ NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN

    Quantity

    58466 units