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Philips Cardiac Telemetry Recall: Updated FDA Classification and What It Means for Patients

  • January 20, 2025
  • KBA Attorneys
  • No Comments

Philips Cardiac Telemetry Recall: Updated FDA Classification and What It Means for Patients

The FDA escalated its recall classification for Philips’ outpatient cardiac telemetry system to a Class I recall. This type of recall is the most serious designation. It indicates a risk of severe injury or death. 

The Philips recall follows reports of two fatalities linked to the device’s failure to flag critical ECG alerts, putting thousands of patients at significant risk.

This latest development in the Philips cardiac monitoring recall impacts approximately 21,000 affected devices. 

The Problem With Philips’ Cardiac Telemetry Systems

We reported on this previously. If you’ve been following our coverage, you may recall our earlier blog post discussing the initial FDA actions and Philips’ efforts to address the problem. For a refresher, read “Philips Recall: What You Need to Know About the Outpatient Telemetry Monitoring System Correction”.

The Philips’ outpatient cardiac telemetry system helps healthcare providers to monitor patients remotely. The recall here involves a software issue that caused failures in ECG alerts. 

These malfunctions could mean critical cardiac events were not detected. That could deprive patients and healthcare providers timely medical intervention. That could prevent serious outcomes. The FDA’s latest update reinforces the severity of these concerns, as detailed in the FDA’s official announcement.

The Broader Impact on Cardiac Device Patients

This recall highlights a recurring issue in cardiac device safety. Heart related recalls are not unique to Philips. At Ketterer, Browne, and Associates, LLC, we are focusing on legal claims involving defective cardiac devices. We have covered pacemakers, defibrillators, and heart valve implants. These devices are life-saving, but when they fail, the consequences can be devastating.

If a cardiac, heart related device injured you or a loved one, we are here to help. You deserve answers and we may be able to help get some. Learn more about your legal rights and the claims process on our defective medical devices lawsuits page.

What Should Patients Do Now?

If you use a Philips outpatient cardiac telemetry system, here’s what you should do immediately per an AI synopsis of the Philips recall:

  1. Contact Your Healthcare Provider: Confirm whether your device is part of the recall and seek guidance on alternative monitoring solutions.
  2. Review the FDA Recall Notice: Visit the FDA’s recall page for details about the issue.
  3. Monitor for Symptoms: Be vigilant about your cardiac health and report any unusual symptoms to your healthcare provider without delay.
  4. Understand Your Legal Rights: If you’ve experienced harm due to a defective cardiac device, you may be entitled to compensation. Our attorneys are available to help guide you through the process.

Don’t rely on this, check the recall yourself and speak with your healthcare provider. Then call us. 

Holding Medical Device Companies Accountable for Defective Devices

At Ketterer, Browne, and Associates, LLC, we advocate tirelessly. This recent escalation of the Philips recall is precisely what we are here for, to help families. Our goal is to ensure patients and families defective devices impact. Contact us at 855-KBA-LAWS (522-5297). 

Stay Informed

For the latest updates on medical device recalls, patient safety, and legal options, follow our blog at KBA Attorneys. Together, we can help build awareness and create a safer future for all.