Philips recalls remote cardiac monitoring software after 2 deaths

01/16/25 at 03:00 AM

Philips recalls remote cardiac monitoring software after 2 deaths 
Modern Healthcare; by Lauren Dubinsky; 1/14/25 
Philips is recalling its remote cardiac monitoring software, which has been associated with 109 reported injuries and two reported deaths, according to the Food and Drug Administration. The agency labeled the action a Class I recall, its most serious designation. ... The recall is related to the company’s Monitoring Service Application, which processes and transmits symptomatic and asymptomatic cardiac events in electrocardiogram data received from the Mobile Cardiac Outpatient Telemetry device. The company and its subsidiary Braemar Manufacturing discovered that the software was not properly handling certain EKG readings between July 2022 and July 2024.

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