BEUDAMED
    FDA Recall Terminated

    HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

    Recall: Z-1199-2009 · Initiated March 30, 2009

    Recall

    Recall Number
    Z-1199-2009
    Event Number
    51455
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 30, 2009
    Posted
    May 19, 2009
    Terminated
    September 4, 2012
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

    Reason

    Rotary energy select switch in affected M4735A devices may fail and prevent the user from turning the device on, rendering the device unusable for monitoring and defibrillation therapy.

    Action

    An Urgent - Medical Device Recall Letter and Notice dated March 2009 were issued to affected customers. Mailings of the Urgent - Medical Device Recall Letter and Notice were handled by Philips Healthcare representatives in each affected geography. Customers were asked to follow the "Actions to be taken by customer/user" section of the Urgent - Medical Device Recall Notice. In this section, customers were instructed to remove the device from service if possible, while they await the correction of their device. If the customer is unable to remove the device from service, they are asked to identify a readily available backup device to use in the event that their device becomes unusable. All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the energy select switch in the affected devices (Mandatory Field Change Order FCO86100076). Contact your local Philips Healthcare representative for additional information or support concerning this issue.

    Distribution

    Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY,GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MACEDONIA, MALAYSIA,MALI, MARTINIQUE, MAURITIUS, MEXICO, MONGOLIA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU,PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO,ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA,THAILAND, TRINIDAD AND TOBAGO, TURKEY,TUNESIA, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS and YEMEN.

    Quantity

    26,992