TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Reported: February 3, 2021 Initiated: March 5, 2020 #Z-1767-2020
Product Description
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
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.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 81,626
- Distribution
- The products were distributed US nationwide. Global distribution.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951. Recalled by Philips North America, LLC. Units affected: 81,626.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-1767-2020.
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