FDA Device recall Z-1766-2020
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231 by Philips North America, citing 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 Inform….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1766-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-05 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
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.
Identifiers
| code_info | Serial Numbers: US00609707 US00609806 US00609799 US03912118 US94208614 US94208908 US02711406 US94208759 US0391…Serial Numbers: US00609707 US00609806 US00609799 US03912118 US94208614 US94208908 US02711406 US94208759 US03916432 US00610259 US03912755 US92008041 US84205167 US03914259 US90806906 US73802986 US03914440 US70901588 US03924349 US03916495 US94209012 US03921163 US03916102 US03918561 US70901531 US03917998 US03916097 US03921176 US03916272 US03918699 US03917268 US92007828 US92007308 US73804950 US73803082 US73802366 US73803410 US03916489 US03917066 US00610411 US03921981 US03913216 US03921046 US03915031 US02711384 US73803628 US03916003 US03914228 US03924137 US03918134 US92008416 US92008297 US70901861 US73803331 US73802704 US84205165 US03915683 US03917164 US03924434 US73803177 US70901697 US92007783 US00609787 US73802951 US73803101 US84205510 US03917261 US03918163 US73802473 US92007700 US03915528 US03919990 US03912545 US03923181 US03919097 US03913306 US73802943 US03918021 US03919848 US02711041 US73804777 US03912514 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1766-2020%22
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