TRx4851A 2 — Class II medical device recall Z-1766-2020
Terminated recall by Philips North America, LLC, reported 2021-02-03, distributed nationwide. The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may n
| Recall number | Z-1766-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-03-05 |
| Classified | 2020-04-22 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2021-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 21,672 |
| Serial numbers | US00309520, US00309525, US00309534, US00309536, US00309543, US00609547, US00609576, US00609580, US00609584, US00609604, US00609623, US00609653, US00609658, US00609669, US00609671, US00609675, US00609686, US00609707, US00609723, US00609734, US00609760, US00609787, US00609789, US00609799, US00609806 and 475 more |
| Model numbers | 862231 |
Product
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1766-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.