Philips Telemetry Transceiver Recall for Heart Rate Display Failure
Philips is recalling TRx4841A telemetry transceivers because they may fail to display heart rates or alarms when used with specific Patient Information Center software.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device failure that prevents the display of vital signs and alarms, creating a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Philips North America, LLC is recalling 81,626 units of the TRx4841A 1.4 GHz IntelliVue Tele TRX (Model Number 862439). The affected devices were distributed nationwide in the United States and globally.
The recall is due to a software compatibility issue. When the TRx4841A is used with a Philips Patient Information Center iX running Release C.02.xx or C.03.01, the ECG signal from monitored patients may not be properly analyzed. In these instances, the Information Center will not display a heart rate and will not generate, display, or annunciate any heart rate or arrhythmia alarms.
Healthcare facilities using these specific device and software combinations should verify their configurations and follow Philips' instructions for corrective action to ensure patient monitoring functions are restored.
The recalled product
- Product
- TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
- Manufacturer
- Philips North America, LLC
- Affected units
- 81,626
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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