TRx4851A 2.4 GHz IntelliVue Tele TRX
Medical device recall Z-1766-2020. 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
- 21,672 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?
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
21,672, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: US00609707 US00609806 US00609799 US03912118 US94208614 US94208908 US02711406 US94208759 US03916432 US00610259 US03912755 US92008041 US84205167 US03914259 US90806906 US73802986 US03914440 US70901588 US03924349 US03916495…
Every code shown here, 1,996 characters
Serial Numbers: US00609707 US00609806 US00609799 US03912118 US94208614 US94208908 US02711406 US94208759 US03916432 US00610259 US03912755 US92008041 US84205167 US03914259 US90806906 US73802986 US03914440 US70901588 US03924349 US03916495 US94209012 US03921163 US03916102 US03918561 US70901531 US03917998 US03916097 US03921176 US03916272 US03918699 US03917268 US92007828 US92007308 US73804950 US73803082 US73802366 US73803410 US03916489 US03917066 US00610411 US03921981 US03913216 US03921046 US03915031 US02711384 US73803628 US03916003 US03914228 US03924137 US03918134 US92008416 US92008297 US70901861 US73803331 US73802704 US84205165 US03915683 US03917164 US03924434 US73803177 US70901697 US92007783 US00609787 US73802951 US73803101 US84205510 US03917261 US03918163 US73802473 US92007700 US03915528 US03919990 US03912545 US03923181 US03919097 US03913306 US73802943 US03918021 US03919848 US02711041 US73804777 US03912514 US03914237 US03912387 US03918469 US90506272 US03921778 US92008308 US02711172 US84205636 US02711200 US03922626 US73802999 US70901679 US03913845 US03913840 US03914512 US73802057 US73802023 US03921834 US03917937 US03913836 US03919098 US92007303 US92007299 US73803355 US03918859 US03915028 US03912536 US73804868 US73804877 US03914601 US03914718 US73804849 US03920179 US02711671 US84205604 US73803885 US92007514 US03915312 US73803872 US03914400 US00610073 US03921800 US03921161 US73802676 US73802860 US03912978 US00609816 US92007307 US03920160 US03920164 US02711604 US03921167 US03921851 US73804308 US73804983 US84205563 US70901608 US73804593 US90806413 US73803785 US03913696 US00610607 US03920760 US03917340 US73804101 US03913540 US03916590 US03913566 US00610692 US00610696 US92007269 US03924465 US03918565 US03913486 US70901458 US73803076 US73804734 US03919980 US03920690 US03921549 US94208633 US02410995 US03918258 US73803762 US92008228 US03917785 US94208699 US00609861 US03921625 US02711356 US03918788 US03921435 US03924361 US03919768 US03914833 US03921590 US03918342 US03919801…
FDA’s list runs to 20,321 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 20,321 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.