Philips Heart Monitor Software Recall Linked to 109 Injuries, 2 Deaths: FDA Issues Class I Warning

Philips has issued a Class I recall, the FDA's most serious classification, for its heart monitor software after discovering a data routing issue that prevented healthcare professionals from reviewing certain electrocardiogram (ECG) events over a two-year period. The recall, which affects approximately 41,300 customers, has been associated with 109 reported injuries and two deaths. The software, used for outpatient monitoring, failed to escalate critical cardiac events such as atrial fibrillation and rapid heartbeats to physicians, potentially delaying crucial medical interventions. Although Philips initiated the recall in November 2024 and informed customers in December, the correction does not require device removal from service.

To mitigate risks, Philips has launched an online “Prescriber Response Site” where healthcare providers can check affected patients and reprocess their ECG data. However, the company will not notify patients directly; instead, healthcare providers are responsible for informing them and updating their care plans. The FDA warned that the software’s failure to escalate certain heart conditions could lead to undetected arrhythmias and even death if left untreated. Philips and its subsidiary, Braemar Manufacturing, are taking corrective action to address the issue and prevent future incidents.