FDA-Device2021-02-03Class II
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
Philips North America, LLC
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.
Sold states
The products were distributed US nationwide. Global distribution.
Affected count
21,672
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1766-2020Don't want to check this manually?
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