Dive Brief:
- Philips recalled heart monitor application software used to process and analyze patient data after the company discovered that some electrocardiogram (ECG) events over two years were not properly routed to healthcare professionals and, therefore, not reviewed by cardiology technicians for health risks.
- The recall has been tied to reports of 109 injuries and two deaths, according to a Food and Drug Administration notice posted Monday. The Class I recall, the FDA’s severest classification, is a correction and does not require removing devices from where they are used or sold.
- Philips started the recall on Nov. 20, 2024, according to the FDA’s recall database. The database shows the recall affects nearly 41,300 customers.
Dive Insight:
Philips’ application software for outpatient monitoring is used to analyze, display and report symptomatic and asymptomatic cardiac events in ECG data received from devices. The data is then sent to and reviewed by healthcare professionals. The FDA notice stated that the application is not intended for patients with potentially life-threatening arrhythmias who require inpatient monitoring.
Philips and its subsidiary Braemar Manufacturing recalled the software because some ECG events received from the application between July 2022 and July 2024 were not properly routed, resulting in events not being reviewed by healthcare professionals. The issue could have led to missing information in reports or missed notifications, which could have impacted providers’ clinical decisions, according to the agency’s notice.
“Some of the ECG events received into the application during this time period met criteria to be escalated back to ordering practitioners, but were not escalated to them,” the FDA stated. These include episodes of atrial fibrillation or pause, conditions where the heart beats abnormally fast and when electrical signals in the heart are delayed or blocked.
Health risks related to the issue include longer periods of undetected or untreated irregular heartbeats and death.
Philips sent customers a letter about the recall on Dec. 18, 2024, according to the FDA’s notice. The company has created a website called the “Prescriber Response Site,” where customers can review which patients have outpatient ECG monitoring and may need data reprocessed.
Philips will not notify patients directly of the recall, however. The FDA notice stated, “If patients have been impacted as part of this issue, health care providers have the responsibility to inform patients and/or update a patient’s care pathway.”