FDAMarch 5, 2020device

TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

453564007261453564007271453564007281989803196951

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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