BEUDAMED
    FDA Enforcement Class II Ongoing

    PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients

    Recall: Z-0857-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0857-2019
    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 TC70 w/trolley Government Bundle, Product 860352, 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

    US21512485 US21512486 US21512487 US21512488 US21512489 US21512490 US31722466 US31722467 US31722468 US31722469 US41513026 US61722772 US61722773 US71621391 US71722865 US71722866 US81208557 US81208558 US81309947 US81411777 US81411819 US81411820 US81621422 US91412024 US91412025 US91412026 US91513515 US91513521 US91513522 US91513585 US91621626 USD1513746 USN1621889 USN1723144 USN1723145 USO1310393 USO1310394 USO1310395 USO1310396 USO1513640 USO1621655 USO1831199 USO1831200 USO1831201 USO1831202 USO1831208 USO1831209 USO1831210 USO1831211 USO1831212 USO1831213 USO1831214 USO1831215 USO1831216 USO1831217 USO1831218 USO1831219

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    57