BEUDAMED
    FDA Enforcement Class II Terminated

    Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX40 is to be 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. The MX40 can provide time-limited local monitoring when it is not connected to the wireless network.

    Recall: Z-1067-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1067-2019
    Event ID
    82264
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 3, 2019
    Initiation Date
    January 25, 2019
    Classification Date
    March 28, 2019
    Termination Date
    April 21, 2020
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX40 is to be 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. The MX40 can provide time-limited local monitoring when it is not connected to the wireless network.

    Reason

    Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor

    Code Info

    Lot 2018-28

    Distribution

    US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT.

    Quantity

    40