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Philips North America, LLC recalls TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 45356400
Recalled February 3, 2021 · FDA recall Z-1767-2020 · Philips North America
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. · FDA Class II
Units
81,626
Sold at
The products were distributed US nationwide. Global distribution.
Description
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.
Product
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →