Philips Faces a Different Kind of Recall in 2025Philips Faces a Different Kind of Recall in 2025
For years the company struggled with recalls over its respiratory devices. Now Phillips contends with a serious recall of its cardiac monitoring software.
January 13, 2025
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It seems as if Philips is not leaving the recalls and device corrections behind in 2024. The Amsterdam, Netherlands-based company has issued a correction for a monitoring service application used with its mobile cardiac outpatient telemetry technology, according to FDA’s website.
The agency said on its site that it has identified this recall as the most serious type and could cause injury or death if used without correction.
Philips and its subsidiary Braemar Manufacturing are correcting the Monitoring Service Application, a service related to Mobile Cardiac Telemetry Monitoring (BTPS-1000) after identifying that some ECG events received into the Monitoring Service Application from July 2022 to July 2024 were not properly routed.
As a result, these events were not reviewed by a cardiology technician for potential reporting to the ordering clinician. This may have led to missing information in reports or missed notifications, both of which could have impacted a healthcare provider’s clinical decision-making.
Some of the ECG events received into the application during this period met the criteria to be escalated back to ordering practitioners but were not escalated to them. These events include algorithm-identified episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third-degree AV block.
In an email, Philips told MD+DI, "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. The service is now working normally, and with patient safety as our number one priority we continue to methodically work through quality at all levels in a multi-year program."
In the email, Philips also said that affected services are only available in the U.S. and that at the time of this notification, it was made aware of reports of two potential adverse events but their cause and the role of the system in the event, if any, is unknown.
Philips has had a tumultuous time with recalls that started in 2021, involving some of its ventilators and sleep apnea machines. Last year, the company resolved a significant portion of its recall issues with a $1 billion settlement.
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