BEUDAMED
    FDA Recall Terminated

    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL 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-0011-2013 · Initiated September 11, 2012

    Recall

    Recall Number
    Z-0011-2013
    Event Number
    63116
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 11, 2012
    Posted
    October 4, 2012
    Terminated
    August 27, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL 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

    HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.

    Action

    The firm, Philips Healthcare, sent an "URGENT-MEDICAL DEVICE RECALL/Field Safety Notice" letter dated September 6, 2012 to its customers. The letter describes the product, problem and actions to be taken by the customer and also identifies what action Philips plans to take to remedy the issue. The customers were instructed to operate the XL and AC power instead of battery power alone; use a battery from a different date of manufacture (must not have the R-2011-12 date of manufacture code) if they need to operate the XL on battery power alone; and use an alternative source for treatment or therapy (i.e., backup defibrillator/monitor) if unable to operate with AC power alone or locate a battery with a different date of manufacture than that identified. Phillips will provide a replacement battery(s) to customers as soon as new production is available. If you need any further information or support concerning this issue, contact your local Philips representative or call Quality Specialists,Recalls at 978-687-1501 or email: [email protected].

    Distribution

    Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM.

    Quantity

    2500 units