Philips Telemetry Transceiver Recall for Heart Rate Display Failure
Philips is recalling 21,672 telemetry transceivers because they may fail to display heart rates or generate 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 is classified as FDA Class II, and the hazard involves a failure to display critical patient data (heart rate) and generate alarms, which poses a risk of harm even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling 21,672 units of the TRx4851A 2.4 GHz IntelliVue Tele TRX telemetry transceiver (Model Number 862231). The affected devices were distributed nationwide in the United States and globally.
The recall was initiated because the ECG signal from patients monitored with these transceivers may not be properly analyzed when used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this malfunction occurs, the Information Center will not display a heart rate or generate, display, or annunciate any heart rate or arrhythmia alarms.
Healthcare facilities using these specific transceivers with the affected software versions should verify their equipment and follow Philips' instructions for remediation. The source text does not specify a consumer action for individual patients, as these are professional medical devices.
The recalled product
- Product
- TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
- Manufacturer
- Philips North America, LLC
- Affected units
- 21,672
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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