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Philips issues correction for cardiac monitoring software due to risk of missed data and notifications

by Gus Iversen, Editor in Chief | January 17, 2025
Cardiology
Philips, in collaboration with its subsidiary Braemar Manufacturing, has issued an urgent medical device correction for its Monitoring Service Application used in conjunction with mobile cardiac outpatient telemetry (MCOT) systems.

The correction addresses a software issue where some electrocardiogram (ECG) data received between July 2022 and July 2024 were improperly routed. The FDA has linked the issue to 109 reported injuries and two deaths.

The impacted software is used to process and analyze ECG data for symptomatic and asymptomatic cardiac events. It is not intended for patients requiring inpatient monitoring for life-threatening arrhythmias. However, due to the software’s failure to escalate certain critical events, there is a risk of undetected or untreated arrhythmias, which may result in adverse outcomes.

According to Philips, algorithm-identified episodes such as atrial fibrillation, ventricular tachycardia, second- or third-degree AV block, and other critical cardiac events were not appropriately reviewed or escalated to the ordering clinicians.

In December 2024, Philips notified affected users via an Urgent Medical Device Correction letter and provided instructions for resolving the issue.

Philips has clarified that the company will not contact patients directly. Instead, healthcare providers are responsible for informing patients about any potential impact on their care. Reprocessed ECGs will be made available on the secure portal, accompanied by a summary report detailing any newly identified events.

The FDA has categorized this as a Class I recall, its most serious designation, due to the potential risk of serious injury or death.

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