Reported Feb 3, 2021 · Terminated

TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411,…

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

    • TRx4851A 2.4 GHz IntelliVue Tele TRX
    • Model Number 862231
    • Includes Service Numbers 453564052401
    • 453564052411
    • 453564052441
    • 453564052451
    • 453564166851
    • 453564166861
Lot codes and dates
  • Serial Numbers

    1,846 of 1,846 codes

    • 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
Amount recalled
21,672

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 11, 2021 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.