FDA Device recall Z-1767-2020
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439 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-1767-2020 |
| 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
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
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: US94348760 US53404426 US11479851 US53404552 US53404773 US65112716 US61307506 US63409602 US6511…Serial Numbers: US94348760 US53404426 US11479851 US53404552 US53404773 US65112716 US61307506 US63409602 US65113980 US11482453 US44801180 US53404420 US00552837 US00554294 US71218273 US53402710 US53402748 US53402489 US44800249 US73729592 US53404994 US44800361 US53406037 US53404431 US00554876 US00554879 US73728988 US52402192 US65112718 US65113706 US65112932 US73731015 US71216309 US63411735 US44801179 US53403403 US71217875 US03862052 US61306876 US53405461 US02656890 US53403885 US50901456 US53403109 US53405111 US65112438 US44800332 US00550542 US00550535 US71217878 US50901335 US71217882 US83233987 US53403371 US00551365 US83231550 US53405148 US00550937 US94348947 US11470201 US11467421 US90741654 US71217797 US63409492 US03863289 US11468736 US90740188 US03864848 US11480781 US11479368 US90739769 US90439076 US11477413 US11478904 US11468946 US71217881 US61307709 US11480777 US90739914 US11476769 US03863203 US11483122 |
|---|
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-1767-2020%22
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