PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the…
Medical device recall Z-0855-2019. 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
- 13239 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 TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
13239, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703…
Every code shown here, 1,991 characters
CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703 CN11204704 CN11204705 CN11204706 CN11204707 CN11204708 CN11204709 CN11204710 CN11204711 CN11204712 CN11204713 CN11204714 CN11204715 CN11204758 CN11204759 CN11204760 CN11204761 CN11204762 CN11204763 CN11204764 CN11204765 CN11204766 CN11204767 CN11204768 CN11204769 CN11204770 CN11204771 CN11204772 CN11204773 CN11204774 CN11204775 CN11204776 CN11204777 CN11204778 CN11204779 CN11204780 CN11204820 CN11306743 CN11306744 CN11306745 CN11306746 CN11306763 CN11306764 CN11306765 CN11306766 CN11306767 CN11306768 CN11306829 CN11306830 CN11306831 CN11306832 CN11306833 CN11306834 CN11510041 CN11510042 CN11510043 CN11510044 CN11510045 CN11510046 CN11510047 CN11510048 CN11510049 CN11510050 CN11510051 CN11510052 CN11510053 CN11510074 CN11510075 CN11510076 CN11510077 CN11510078 CN11510079 CN11510080 CN11510081 CN11510082 CN11510083 CN11510084 CN11510085 CN11510086 CN11510087 CN11510088 CN11510089 CN11510090 CN11510091 CN11510092 CN11510093 CN11510094 CN11510095 CN11510096 CN11510097 CN11510098 CN11630118 CN11630119 CN11630120 CN11630121 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630127 CN11630128 CN11630129 CN11630130 CN11630131 CN11630137 CN11630139 CN11630140 CN11630141 CN11630142 CN11630149 CN11630150 CN11630151 CN11630152 CN11630153 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630161 CN11630162 CN11630163 CN11630164 CN11630165 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11731415 CN11731422 CN11731423 CN11731424 CN11731425 CN11731426 CN11731427 CN11731428 CN11731429 CN11731430 CN11731431 CN11731432 CN11731433 CN11731434 CN11731435 CN11731436 CN11731437 CN11731438 CN11731439 CN11731440 CN11731441 CN11731442 CN11731443 CN11731444…
FDA’s list runs to 156,154 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 156,154 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.