The correction addresses a software issue in the Monitoring Service Application that led to missed ECG data and notifications, potentially impacting patient care.


Summary: Philips and its subsidiary Braemar Manufacturing are correcting a software issue in the Monitoring Service Application used for Mobile Cardiac Outpatient Telemetry (BTPS-1000) that caused some ECG events to go unreviewed, potentially leading to missed diagnoses of arrhythmias such as atrial fibrillation and ventricular tachycardia. The issue may have affected data from July 2022 to July 2024. The FDA, which classified the recall as its most serious type, reported 109 injuries and two deaths related to the issue. Health care providers are instructed to review affected data and notify impacted patients as Philips will not contact them directly.

Key Takeaways:

  1. Software Issue Identified: Philips discovered that some ECG events from July 2022 to July 2024 were not properly routed in its Monitoring Service Application, resulting in missed reviews and notifications.
  2. FDA-Classified Serious Recall: The recall, categorized as the FDA’s most serious type, highlights risks of undetected arrhythmias, with 109 reported injuries and two deaths linked to the issue.
  3. Provider Responsibility: Philips will not contact patients directly; health care providers must review affected data and inform patients whose care may have been impacted.

Philips and its subsidiary Braemar Manufacturing are correcting the Monitoring Service Application, a service related to Mobile Cardiac Telemetry Monitoring (BTPS-1000), after identifying that some electrocardiogram (ECG) events received into the Monitoring Service Application from July 2022 to July 2024 were not properly routed. 

As a result, these events were not reviewed by a cardiology technician for potential reporting to the ordering clinician. This may have led to missing information in reports or missed notifications, both of which could have impacted a health care provider’s clinical decision-making.

Some of the ECG events received into the application during this time period met criteria to be escalated back to ordering practitioners but were not escalated to them. These events include algorithm-identified episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third-degree AV block.

The use of affected product may cause serious adverse health consequences, including longer periods of undetected or untreated irregular heartbeats (arrhythmias) and death. The US Food and Drug Administration (FDA) is aware of 109 reported injuries and two reports of death related to this issue.

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. 

The Philips (Braemer) Monitoring Service Application software is intended to process, analyze, display, and report symptomatic and asymptomatic cardiac events in ECG data received from compatible devices. The data is then reviewed by qualified health care professionals. It is not intended for use on patients with potentially life-threatening arrhythmias who require inpatient monitoring.

Affected Product

  • Monitoring Service Application for Mobile Cardiac Outpatient Telemetry MCOT (BTPS-1000)

What to Do  

  • Check the Philips Prescriber Response Site at https://prs.gobio.com to review which patients who had outpatient ECG monitoring may need to have data reprocessed (data collected from July 2022 to July 2024). 
  • Philips will not communicate with patients directly about this issue, according to a medical device recall notification from the FDA. If patients have been impacted as part of this issue, health care providers have the responsibility to inform patients and/or update a patient’s care pathway.

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