BEUDAMED
    FDA Recall Terminated

    IntelliVue X3 Patient Monitor.

    Recall: Z-1315-2018 · Initiated November 17, 2017

    Recall

    Recall Number
    Z-1315-2018
    Event Number
    78732
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 17, 2017
    Posted
    April 6, 2018
    Terminated
    September 16, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    IntelliVue X3 Patient Monitor.

    Reason

    The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.

    Action

    Philips will contact customers with affected devices to arrange a correction of the issues. Firm plans a Software update of the affected devices and Replacement of the display assembly.

    Distribution

    48 Foreign Accounts

    Quantity

    975 (updated 8-14-18)