Philips Heart Monitor Application Recalled Following Two Associated Deaths

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Philips has initiated a correction for its Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry (MCOT) systems after discovering a software issue that could lead to missed information or notifications, potentially impacting patient care. The U.S. Food and Drug Administration (FDA) has classified this recall as the most serious type, noting the potential for significant injury or death if the issue is not addressed.

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The affected product, the BTPS-1000, was identified as having an error that caused some electrocardiogram (ECG) events received between July 2022 and July 2024 to be improperly routed. As a result, critical data was not reviewed by cardiology technicians, leading to potential delays in diagnosis or treatment of conditions such as atrial fibrillation, ventricular tachycardia, and heart block. These issues may have contributed to 109 reported injuries and two deaths. Health care providers are advised to log into the Philips Prescriber Response Site to determine if their patients require data reprocessing and to update care pathways as needed.

Philips has instructed affected users to review their patient lists, decide whether to reprocess ECG data, and acknowledge receipt of the correction notice through the secure online portal. The company will generate reports for reprocessed data and notify providers of any newly identified critical events. However, Philips will not contact patients directly about this matter, leaving communication responsibilities to health care providers.

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The Monitoring Service Application is designed to analyze and report symptomatic and asymptomatic cardiac events but is not intended for use with patients requiring inpatient monitoring. The FDA is urging health care professionals and consumers to report adverse reactions or issues related to this device to its MedWatch program. Philips has also set up a dedicated response line to assist users with questions or concerns about this correction at 888-521-1684.