Philips Recall – the Philips Heart Monitoring Software Recall

The recent Philips recall presents another potential product liability case involving cardiac devices. This device concerns cardiac monitoring. Our product liability lawyers are at the forefront of heart-related medical device cases.

This heart monitoring device recall comes after two deaths. It appears the software fails to send alerts.  Fortunately, it may impact only a small number of people.  As reported on Mass Device:

“On Dec. 18, 2024, Philips and its subsidiary Braemar Manufacturing sent health provider customers an Urgent Medical Device Correction, notifying them         that, in some cases, the monitoring service application for its MCOT (BTPS-1000) devices failed to route some ECG events properly.

     In a statement shared with MassDevice, Philips said the problem involved a small percentage of ECG events.

“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.””

We hope the death toll remains at two and no one else is injured. A Philips Telemetry failure appears to be a serious event that could cause serious injury or death. The Phillips FDA recall is an important public message to heed.

Philips Outpatient Telemetry Monitoring System Recall

The U.S. Food and Drug Administration (FDA) issued a notice regarding a critical correction for the Philips Outpatient Telemetry Monitoring System, specifically its Monitoring Service Application used on mobile devices.

What Is the Philips Outpatient Telemetry System?

The Philips Outpatient Telemetry Monitoring System is a critical tool used in healthcare for remotely monitoring patients’ cardiac activity. Designed to transmit vital data via mobile applications, it provides real-time insights to medical professionals. However, when such systems fail or contain flaws, patient safety can be at risk.

Why Did the Philips Recall Occur?

Philips initiated the recall due to issues with the Monitoring Service Application’s performance on mobile devices. According to the FDA notice, the device may not consistently transmit accurate or timely patient data. This flaw could delay medical interventions, potentially leading to severe injuries or worse for patients relying on continuous and accurate monitoring.

The FDA classified this as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious health issues is remote.

Who Might the Philips Telemetry Recall Affect?

This recall affects:

• Patients using the Philips Outpatient Telemetry Monitoring System.
• Healthcare providers relying on this application to monitor patient health.
• Medical facilities integrating this technology into their care systems.

If you or a loved one has used this system and experienced delays or errors in monitoring, it’s important to understand your rights.

What Actions Should You Take Concerning the Philips Outpatient Telemetry Monitoring System?

Based on the FDA Philips recall notice and our experience:

• For Patients: Speak to your healthcare provider immediately if you suspect your monitoring system is malfunctioning or providing inaccurate data. Request an alternative monitoring solution if necessary.
• For Healthcare Providers: Follow Philips’ correction guidelines and ensure staff are aware of the potential risks. Contact Philips or the FDA for further updates or technical support. Make patients aware of the Philips Telemetry failure and monitor them. 
• For Anyone Injured: If you or a loved one suffered Philips Telemetry injury, an injury related to the Philips Telemetry recall or any heart device, consult an experienced attorney to explore potential compensation for damages.

How Ketterer, Browne, and Associates, LLC Can Help

Defective medical devices can lead to serious injuries, financial strain, and emotional distress. Our firm has years of experience handling personal injury cases related to medical devices, including cardiac devices. If you believe the Philips Outpatient Telemetry Monitoring System caused harm, we are here to help you navigate your legal options.

Stay Informed About Medical Device Safety

The FDA’s recall database is a valuable resource for staying updated on potential risks associated with medical devices. At KBA Attorneys, we also provide regular updates on recalls and safety alerts. Visit our blog for more information. Our heart device related page highlights several recent cardiac device failures including the Impella heart pump, the RMU compression device, the Accolade pacemaker, the PolarX, and the Heartmate II and Heartmate 3.

Contact Us for a Free Consultation

If you have been affected by the Philips Outpatient Telemetry Monitoring System recall, don’t wait. Contact KBA today for a free consultation – 855-KBA-LAWS (522-5297). We are dedicated to holding negligent manufacturers accountable and securing justice for our clients. Let us help you protect your rights and get the compensation you deserve.