BEUDAMED
    FDA Recall Terminated

    Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491

    Recall: Z-1155-2014 · Initiated February 18, 2014

    Recall

    Recall Number
    Z-1155-2014
    Event Number
    67473
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 18, 2014
    Posted
    March 7, 2014
    Terminated
    September 11, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491

    Reason

    MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing

    Action

    Philips Healthcare issued and Urgent Medical Device Correction notification/Field Safety Notice on 02/18/14 to inform customers of the issue, Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving the hardware upgrade, provided that if you observe that the MRx is displaying a Red X in the Ready For Use (RFU) indicator\during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this is observed you should turn the Therapy Knob to Monitor. An INOP message describing the failure is displayed. If needed, run an Operational Check for further information. If the condition persists, take the device out of use and call for service. Identify a readily available backup defibrillator to use in the event the affected HeartStart MRx fails to deliver therapy. Philips will perform a hardware upgrade (replace therapy boards) free of charge to be installed by a Philips Field Service Engineer. Contact your local Philips representative or call us at 1-800-722-9377.

    Distribution

    Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA MALAYSIA MEXICO MOZAMBIQUE MYANMAR (Burma) NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NORWAY PAKISTAN PERU POLAND PORTUGAL QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKMENISTAN UNITED ARAB EMIRATES UNITED KINGDOM VIET NAM

    Quantity

    3541 units