Philips North America, LLC recalls TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 4535640072…

Recall date

March 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1767-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

The products were distributed US nationwide. Global distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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