BEUDAMED
    FDA Recall Terminated

    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 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

    Recall: Z-0871-2013 · Initiated January 28, 2013

    Recall

    Recall Number
    Z-0871-2013
    Event Number
    64201
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 28, 2013
    Posted
    February 21, 2013
    Terminated
    September 3, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 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

    Reason

    Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use

    Action

    Philips Healthcare sent an Urgent Medical Device Recall letter dated January 2013 on January 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if the Philips HeartStart XL+ Defibrillator/Monitor is first powered on and then there is disconnection or an interruption in AC power, the device may be locked out of clinical mode until the user enters the service mode password and performs an Operational Check. Users are provided with the Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Customers were advised to follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a software upgrade to customers with affected units free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. For questions regarding this recall call 978-687-1501.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.

    Quantity

    3785 units