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