Reported Feb 27, 2019 · Ongoing

PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the…

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Lot codes and dates
  • 2,717 of 2,717 codes

    • CN80811000
    • CN80811001
    • F5N7000106
    • F5N7000107
    • F5O7000002
    • F5O7000024
    • F5O7000027
    • F5O7000037
    • F5O7000078
    • F5O7000085
    • F5O7000091
    • F5O7000093
    • US10901771
    • US10901772
    • US10901773
    • US10901774
    • US10901775
    • US10901776
    • US10901777
    • US10901778
    • US10901779
    • US10901782
    • US10901783
    • US10901784
    • US10901785
    • US10901786
    • US10901787
    • US10901788
    • US10901789
    • US10901790
    • US10901791
    • US10901792
    • US10901793
    • US10901794
    • US10901795
    • US10901796
    • US10901797
    • US10901798
    • US10901799
    • US10901800
    • US10901801
    • US10901802
    • US10901803
    • US10901804
    • US10901805
    • US10901806
    • US10901807
    • US10901808
    • US10901809
    • US10901810
    • US10901811
    • US10901812
    • US10901813
    • US10901814
    • US10901815
    • US10901816
    • US10901817
    • US10901818
    • US10901819
    • US10901821
Amount recalled
15,064

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.