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.
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"Acting fast on post market surveillance signals, we proactively identified a software configuration issue and reported a medical device correction, offering clinicians the possibility of reprocessing potentially affected prescriptions," a Philips spokesperson said in a statement.
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. As a result, cardiology technicians were not reporting these readings to the ordering clinicians, potentially leading to missing information in reports or missed alerts.
Philips sent all affected customers a notification on Dec. 18 with details on how to determine which patients might have been affected. The company said it will not communicate directly with patients regarding the recall, instead leaving it to clinicians to inform patients.
This is not the only recall the company is dealing with. Philips’ Respironics business has been facing issues with some of its sleep apnea products since June 2021 when it issued a recall of 15 million devices.
The devices contain polyester-based polyurethane foam, which can break down and be inhaled or swallowed by the patient and cause serious injury, according to the FDA. Since April 2021, the agency has received more than 116,000 medical device reports associated with the sleep apnea devices, including 561 deaths.
The FDA identified more affected sleep apnea devices over the years. Most recently, in January 2024 the FDA and Department of Justice issued a consent decree against Philips Respironics. The company agreed to discontinue the sale of certain sleep apnea product lines.