TRx4841A 1.4 GHz IntelliVue Tele TRX
Medical device recall Z-1767-2020. Published in FDA’s Enforcement Report on Feb 3, 2021.
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 3, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 81,626 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?
The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs, the Information Center will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alarms.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
81,626, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: US94348760 US53404426 US11479851 US53404552 US53404773 US65112716 US61307506 US63409602 US65113980 US11482453 US44801180 US53404420 US00552837 US00554294 US71218273 US53402710 US53402748 US53402489 US44800249 US73729592…
Every code shown here, 1,996 characters
Serial Numbers: US94348760 US53404426 US11479851 US53404552 US53404773 US65112716 US61307506 US63409602 US65113980 US11482453 US44801180 US53404420 US00552837 US00554294 US71218273 US53402710 US53402748 US53402489 US44800249 US73729592 US53404994 US44800361 US53406037 US53404431 US00554876 US00554879 US73728988 US52402192 US65112718 US65113706 US65112932 US73731015 US71216309 US63411735 US44801179 US53403403 US71217875 US03862052 US61306876 US53405461 US02656890 US53403885 US50901456 US53403109 US53405111 US65112438 US44800332 US00550542 US00550535 US71217878 US50901335 US71217882 US83233987 US53403371 US00551365 US83231550 US53405148 US00550937 US94348947 US11470201 US11467421 US90741654 US71217797 US63409492 US03863289 US11468736 US90740188 US03864848 US11480781 US11479368 US90739769 US90439076 US11477413 US11478904 US11468946 US71217881 US61307709 US11480777 US90739914 US11476769 US03863203 US11483122 US83231713 US11469041 US02656232 US03860015 US03865996 US73731254 US03863933 US11472503 US11166777 US94350014 US71216576 US73729003 US03859909 US03863291 US53405452 US00553108 US11468063 US91944592 US84137301 US03859856 US11471545 US91944588 US53402706 US53404811 US03863598 US11479477 US03865320 US71214310 US11480447 US84137955 US11485811 US03858616 US65112287 US91943592 US90740923 US84138344 US03863893 US71219972 US11482060 US11470580 US03862139 US03863412 US03864916 US11490636 US65112308 US63409285 US83231925 US63411840 US11473308 US61307371 US94347811 US71217367 US83233757 US11490472 US11478644 US44800327 US11472476 US11477950 US53406036 US53406000 US71217877 US63410601 US11470815 US94347131 US11469286 US94346807 US44800314 US44800308 US84135185 US94347833 US91944790 US73723262 US91944590 US11486554 US11481315 US03862872 US03860965 US84135017 US61307275 US90740547 US90740062 US11473124 US65112381 US00551266 US11485535 US71216220 US03865100 US03864729 US71214936 US03863998 US11489560 US11167106 US73728042 US11478910 US11479934 US11486663 US73723938 US02657041…
FDA’s list runs to 25,953 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.
The products were distributed US nationwide. Global distribution.
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Mar 5, 2020.
- FDA classified it on Apr 22, 2020.
- FDA’s Enforcement Report published it on Feb 3, 2021.
- FDA terminated it on Feb 11, 2021.
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 25,953 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.