BEUDAMED
    FDA Recall Open, Classified

    IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

    Recall: Z-0020-2025 · Initiated June 14, 2023

    Recall

    Recall Number
    Z-0020-2025
    Event Number
    95324
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 14, 2023
    Posted
    October 4, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

    Reason

    Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.

    Action

    PHILIPS issued Urgent Field Safety Notice (2023-CC-HPM-019) on 6/14/23. Letter states reason for recall, health risk and action to take: " Please be aware that without Option C01 (Full Arrhythmia) the device will not provide the yellow alarms for enhanced arrhythmia detection. " Review the contents of this letter with your staff. " Pass this notice to all those who need to be aware within your organization or to any organization where the affected devices might have been transferred. 5. Actions taken by Philips to correct the problem Philips Representative will contact you to arrange reload of current device's software to enable missing software options (C0l, C13, C51, C54). If you need any further information, please contact your local Philips representative

    Distribution

    Foreign Only: Denmark France Germany Japan United Kingdom

    Quantity

    153 units OUS