Problems With Recalled Philips Heart Monitoring Application Linked to Injuries, Deaths

Faulty software program designed to be used with Philips medical devices is at the center of a class I recall.

Federal health officials have issued a device correction for the Philips Mobile Cardiac Telemetry Monitoring system’s Service software, following reports of critical malfunctions that have resulted in at least 100 patient injuries and two deaths.

The Philips Monitoring Service software processes, analyzes, and reports cardiac symptoms and events based on electrocardiogram (ECG) data collected by Philips devices. This data is gathered during office and outpatient visits, and is then processed after the patient has left.

The software flags serious or life-threatening events, to help physicians make informed medical decisions and communicate findings effectively with patients. However, if the software fails to accurately report critical information, it can result in delayed interventions or the need for immediate medical attention.

The U.S. Food and Drug Administration (FDA) announced a class I Philips Monitoring Service recall on January 13, warning that the monitoring service may fail to properly record events of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third degree AV block.

Officials are warning that such failures could delay critical medical diagnoses and treatments, potentially leading to severe patient harm or death.

Philips indicated that a problem was identified among some Monitoring Service Applications from July 2022 to July 2024. In these cases, serious cardiac events were not properly flagged for doctor review and were not reviewed by a technician or cardiologist.

According to the recorded events, the software failed to report serious events to the ordering doctor as intended, including episodes of atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and second- or third-degree AV block.

These reporting failures left periods of irregular heartbeats undetected and untreated, ultimately contributing to 109 patient injuries and two fatalities.

The FDA has classified the recall as a Class I recall due to the potential for the device’s failure to result in serious and potentially fatal injuries.

While the recall does not recommend the devices be removed from use or the market entirely, Philips has issued a correction notice for the Philips Monitoring Service Application for Mobile Cardiac Outpatient Telemetry MCOT (BTPS-1000).

Philips stated that it will not communicate directly with patients about the issue. Instead, doctors and healthcare providers are responsible for reviewing the recall and correction details and notifying patients if they are affected.

The company recommends doctors review the FAQs accompanying the device correction and log into the Prescriber Response Site using the Location Code from the correction letter. Doctors should review the patient list to identify individuals whose data requires reprocessing, and determine if updates to their medical recommendations are needed.

Patients who have suffered side effects related to the software issue should report them to the FDA’s Adverse Event Reporting Program.