PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the…
Medical device recall Z-0854-2019. 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
- 11332 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 TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
11332, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CN11102314 CN11102315 CN11102316 CN11102317 CN11203436 CN11203443 CN11203444 CN11203453 CN11203454 CN11203455 CN11304748 CN11304749 CN11304762 CN11304772 CN11304773 CN11304802 CN11304803 CN11304805 CN11304806 CN11304809 CN11406020…
Every code shown here, 1,991 characters
CN11102314 CN11102315 CN11102316 CN11102317 CN11203436 CN11203443 CN11203444 CN11203453 CN11203454 CN11203455 CN11304748 CN11304749 CN11304762 CN11304772 CN11304773 CN11304802 CN11304803 CN11304805 CN11304806 CN11304809 CN11406020 CN11406033 CN11406034 CN11507236 CN11507237 CN11507238 CN11507259 CN11507260 CN11507261 CN11507262 CN11507263 CN11507264 CN11630099 CN11630100 CN11630101 CN11630102 CN11630103 CN11630104 CN11630105 CN11630106 CN11630107 CN11630108 CN11630109 CN11630110 CN11630111 CN11630112 CN11630113 CN11630114 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630128 CN11630129 CN11630130 CN11630131 CN11630132 CN11630133 CN11630134 CN11630135 CN11630136 CN11630138 CN11630139 CN11630140 CN11630141 CN11630142 CN11630143 CN11630144 CN11630145 CN11630146 CN11630147 CN11630148 CN11630149 CN11630150 CN11630151 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630164 CN11630165 CN11630166 CN11630173 CN11630174 CN11630175 CN11630176 CN11630177 CN11630178 CN11630179 CN11630180 CN11630181 CN11630182 CN11630183 CN11630184 CN11630185 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11630196 CN11630197 CN11630198 CN11630199 CN11630200 CN11630201 CN11630202 CN11630203 CN11630204 CN11731556 CN11731557 CN11731558 CN11731559 CN11731560 CN11731561 CN11731562 CN11731563 CN11731564 CN11731565 CN11731566 CN11731567 CN11731568 CN11731575 CN11731576 CN11731577 CN11731578 CN11731579 CN11731580 CN11731581 CN11731582 CN11731583 CN11731584 CN11731585 CN11731586 CN11731593 CN11731594 CN11840066 CN11840067 CN11840068 CN11840069 CN11840071 CN11840072 CN11840073 CN11840080 CN11840081 CN11840082 CN11840083 CN11840084 CN11840085 CN11840086 CN11840087 CN11840088 CN11840089 CN11840090 CN11840091 CN11840092 CN11840093 CN11840094 CN11840095 CN11840096 CN11840097 CN11840098 CN11840099 CN11840100 CN11840101 CN11840103 CN11840104 CN11840105 CN11840106 CN11840107 CN11840108 CN11840109…
FDA’s list runs to 133,270 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 133,270 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.