Recall – ECG Patient Information Center fails to properly analyze results

Company: Philips North America, LLC
Date of Enforcement Report: 4/29/2020
Class II

PRODUCT

TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861

Recall Number: Z-1766-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Philips North America, LLC on 3/5/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

21,672

DISTRIBUTION

US Nationwide and International

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