PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the…
Medical device recall Z-0853-2019. Published in FDA’s Enforcement Report on Feb 27, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 27, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 15,064 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
15,064, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CN80811000 CN80811001 F5N7000106 F5N7000107 F5O7000002 F5O7000024 F5O7000027 F5O7000037 F5O7000078 F5O7000085 F5O7000091 F5O7000093 US10901771 US10901772 US10901773 US10901774 US10901775 US10901776 US10901777 US10901778 US10901779…
Every code shown here, 1,991 characters
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 US10901822 US10901823 US10901824 US10901825 US10901826 US10901829 US10901830 US10901831 US10901832 US10901833 US10901834 US10901835 US10901836 US10901837 US10901838 US10901839 US10901840 US10901841 US10901842 US10901843 US10901844 US10901845 US10901846 US10901847 US10901848 US10901850 US10901851 US10901852 US10901853 US10901854 US10901855 US10901856 US10901857 US10901858 US10901859 US10901860 US10901861 US10901862 US10901863 US10901864 US10901865 US10901866 US10901867 US10901868 US10901869 US10901870 US10901871 US10901872 US10901873 US10901874 US10901887 US10901888 US10901889 US10901890 US10901891 US10901892 US10901893 US10901894 US10901895 US10901896 US10901897 US10901898 US10901899 US10901900 US10901901 US10901902 US10901907 US10901908 US10901909 US10901910 US10901911 US10901912 US10901913 US10901914 US10901915 US10901916 US10901917 US10901918 US10901919 US10901920 US10901921 US10901922 US10901923 US10901924 US10901925 US10901926 US10901927 US10901928 US10901929 US10901930 US10901931 US10901932 US10901933 US10901934 US10901938 US10901939 US10901940 US10901941 US10901942 US10901943 US10901944 US10901945 US10901946 US10901947 US10901948 US10901949 US10901950 US10901951 US10901952 US10901953 US10901954 US10901955 US10901956 US10901957 US10901958 US10901959 US10901960 US10901961 US10901962 US10901963 US10901964…
FDA’s list runs to 178,594 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic distribution nationwide. Foreign distribution worldwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 9, 2019.
- FDA classified it on Feb 21, 2019.
- FDA’s Enforcement Report published it on Feb 27, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, LLC, of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 178,594 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.