BEUDAMED
    FDA Enforcement Class II Ongoing

    PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

    Recall: Z-0859-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0859-2019
    Event ID
    81957
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2019
    Initiation Date
    January 9, 2019
    Classification Date
    February 21, 2019
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

    Reason

    Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

    Code Info

    US41510645 US41510646 US71630792 USN1206382 USN1206383 USN1409879 USO1631023

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    7