PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the…
Medical device recall Z-0856-2019. 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
- 14067 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 TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
14067, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CN11201318 CN11201319 CN11201320 CN11201321 CN11201322 CN11201323 CN11201324 CN11201325 CN11201326 CN11201327 CN11201328 CN11201329 CN11201330 CN11201331 CN11201332 CN11201333 CN11201334 CN11201335 CN11201336 CN11201337 CN11201338…
Every code shown here, 1,991 characters
CN11201318 CN11201319 CN11201320 CN11201321 CN11201322 CN11201323 CN11201324 CN11201325 CN11201326 CN11201327 CN11201328 CN11201329 CN11201330 CN11201331 CN11201332 CN11201333 CN11201334 CN11201335 CN11201336 CN11201337 CN11201338 CN11201339 CN11201340 CN11201341 CN11201342 CN11201343 CN11201344 CN11201345 CN11201346 CN11201347 CN11201348 CN11201349 CN11201350 CN11201351 CN11201352 CN11201353 CN11201354 CN11201355 CN11201356 CN11201357 CN11201358 CN11201359 CN11201360 CN11201361 CN11201362 CN11201363 CN11201364 CN11201365 CN11201366 CN11201371 CN11201372 CN11201373 CN11201374 CN11201375 CN11201376 CN11201377 CN11201378 CN11201379 CN11201380 CN11201381 CN11201382 CN11201383 CN11201384 CN11201385 CN11201386 CN11201387 CN11201388 CN11201389 CN11201390 CN11201391 CN11201392 CN11201393 CN11201394 CN11302185 CN11302186 CN11302187 CN11302188 CN11302190 CN11302191 CN11302192 CN11302193 CN11302194 CN11302195 CN11302196 CN11302197 CN11302198 CN11302199 CN11302200 CN11302201 CN11302202 CN11302203 CN11302204 CN11302205 CN11302206 CN11302207 CN11302208 CN11302209 CN11302210 CN11302211 CN11302212 CN11302213 CN11302214 CN11302215 CN11302216 CN11302217 CN11302218 CN11302219 CN11302220 CN11302221 CN11302222 CN11302223 CN11302224 CN11302225 CN11302226 CN11302227 CN11302228 CN11302229 CN11302230 CN11302231 CN11302232 CN11302233 CN11302234 CN11302235 CN11302236 CN11302237 CN11302238 CN11302239 CN11302240 CN11302241 CN11302242 CN11302243 CN11302244 CN11302245 CN11302246 CN11404143 CN11404144 CN11404145 CN11404146 CN11404147 CN11404148 CN11404149 CN11404150 CN11404151 CN11404152 CN11404153 CN11404154 CN11404155 CN11404156 CN11404157 CN11404158 CN11404159 CN11404160 CN11404161 CN11404162 CN11404163 CN11404164 CN11404165 CN11404166 CN11404167 CN11404168 CN11404169 CN11404170 CN11404171 CN11404172 CN11404173 CN11404174 CN11404175 CN11404176 CN11404177 CN11404178 CN11404179 CN11404180 CN11404181 CN11404182 CN11404183 CN11404184 CN11404185 CN11404186 CN11404187 CN11404188 CN11404189…
FDA’s list runs to 166,091 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 166,091 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.