BEUDAMED
    FDA Enforcement Class II Terminated

    Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.

    Recall: Z-2328-2015 · Reported August 12, 2015

    Enforcement

    Recall Number
    Z-2328-2015
    Event ID
    71584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2015
    Initiation Date
    June 5, 2015
    Classification Date
    August 4, 2015
    Termination Date
    February 25, 2019
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.

    Reason

    Multiple software and hardware issues with device that can affect its function.

    Code Info

    Serial Numbers in the following ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022

    Distribution

    Worldwide Distribution - US Nationwide including PUERTO RICO, Canada, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICA, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GABON, GERMANY, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, Jordan, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBERIA, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MALAYSIA, MALTA, MAURITIUS, MEXICO, MOROCCO, MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SEYCHELLES, SINGAPORE, SLOVAKIA (Slovak Republic), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, United Republic of TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM and ZIMBABWE.

    Quantity

    13,168 devices