BEUDAMED
    FDA Recall Open, Classified

    IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.

    Recall: Z-0292-2018 · Initiated August 23, 2017

    Recall

    Recall Number
    Z-0292-2018
    Event Number
    78736
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    August 23, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.

    Reason

    Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors

    Action

    Philips sent an Urgent Medical Device Correction letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips will provide software update and is provding interim instructions for the operator. For questions contact your local Philips representative.

    Distribution

    Worldwide Distribution and US Nationwide

    Quantity

    7071