BEUDAMED
    FDA Recall Terminated

    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.

    Recall: Z-0105-2015 · Initiated October 3, 2014

    Recall

    Recall Number
    Z-0105-2015
    Event Number
    69348
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    HGM
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    October 3, 2014
    Posted
    October 21, 2014
    Terminated
    January 31, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.

    Reason

    Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

    Action

    Philips Healthcare issued on 10/3/14 the Urgent Medical Device Correction notification/Field Safety Notice. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a software upgrade free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for service. 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: During the interim period until the SW is upgraded please make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. Please review this information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.

    Quantity

    118 units