BEUDAMED
    FDA Recall Terminated

    Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities

    Recall: Z-2625-2010 · Initiated August 31, 2010

    Recall

    Recall Number
    Z-2625-2010
    Event Number
    56646
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 31, 2010
    Posted
    September 29, 2010
    Terminated
    February 15, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M8102A are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities

    Reason

    Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.

    Action

    Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks. Affected products may continue to e used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP at power-up. If you experience this INOP or there is no sound from your X2/MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative at 1-800-722-9377.

    Distribution

    Worldwide Distribution - USA and the countries of : ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CHINA CZECH REPUBLIC DENMARK EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LIBYAN ARAB JAMAHIRI LITHUANIA MALAYSIA MAURITIUS MEXICO MOROCCO NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PAKISTAN PALESTINE PARAGUAY POLAND PORTUGAL QATAR ROMANIA RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN THAILAND TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN and VIET NAM

    Quantity

    19,400 units