BEUDAMED
    FDA Recall Terminated

    Philips IntelliVue Module Measurement X2 Model: M3002A

    Recall: Z-0854-2016 · Initiated January 4, 2016

    Recall

    Recall Number
    Z-0854-2016
    Event Number
    73209
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    January 4, 2016
    Terminated
    March 1, 2021
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips IntelliVue Module Measurement X2 Model: M3002A

    Reason

    The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor

    Action

    Philips Healthcare issued the Field Safety Notice on January 4, 2016, and informed 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. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Until your software is upgraded, please make sure that the ST Analysis is switched ON when using STE measurement in the Hexad 12-lead ECG Monitoring. This can be done by entering the ST Analysis Menu and select ST Analysis to On. For more detailed information, please refer to the Instructions for Use (IFU) of your host monitor or to the X2 Measurement Module IFU. Philips will provide a software correction free of charge. For further questions please call (978) 659-3000.

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.

    Quantity

    13,300