BEUDAMED
    FDA Enforcement Class II Ongoing

    IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    Recall: Z-1693-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1693-2019
    Event ID
    82696
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    March 28, 2019
    Classification Date
    May 31, 2019
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    Reason

    The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

    Code Info

    All revision B.X versions are affected.

    Distribution

    Worldwide distribution - US Nationwide and to 71 countries.