BEUDAMED
    FDA Enforcement Class II Terminated

    Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

    Recall: Z-0544-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0544-2021
    Event ID
    86848
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2020
    Initiation Date
    November 18, 2020
    Classification Date
    December 8, 2020
    Termination Date
    July 22, 2021
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

    Reason

    Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

    Code Info

    Serial Numbers: US: DE73607502 DE73607498 OUS: System Serial Number DE95038935 DE73608191 DE73608209 DE73601727 DE73604240 DE73601547 DE73601596 DE73604182 DE83617535 DE73608259 DE83617500 DE83617522 DE73601651

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.

    Quantity

    16 total: 2 units US ; 14 OUS