FDA Announces Class I Recall of Philips Heart Monitoring Software Linked to Patient Injuries and Deaths

The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most severe recall classification—of Philips’ software for its Mobile Cardiac Outpatient Telemetry (MCOT) devices. The recall was prompted by a critical software failure that prevented certain high-risk electrocardiogram (ECG) alerts from being transmitted to trained cardiology technicians.

The issue, which spanned from July 2022 to July 2024, has been linked to 109 reported injuries and two patient deaths. Impacted cardiac events include suspected atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, pauses, and advanced atrioventricular blocks (second or third-degree).

On December 18, 2024, Philips and its subsidiary, Braemar Manufacturing, issued customers an Urgent Medical Device Correction using the affected software. The correction includes guidance on reviewing patient data to identify cases requiring reprocessing. Customers were advised to follow the instructions to assess and update patient records. Philips will notify healthcare providers by email once reprocessed ECG data is available, summarizing any new cardiac events identified in the updated reports.

The FDA emphasized that Philips will not directly communicate with patients about the recall. Instead, healthcare providers are responsible for notifying patients and updating care plans as necessary.

For additional information on the recall, healthcare professionals and impacted facilities can visit the FDA’s website or contact Philips directly.

Contact The Ammons Law Firm for Legal Representation Involving Defective Products

If you or a loved one has been injured or killed due to a defective heart monitor, the Ammons Law Firm is here to help. Our dedicated legal team understands the devastating impact of these tragic incidents on families, and we have a proven track record of holding manufacturers accountable for defective products.

Contact the Ammons Law Firm today for a free consultation to discuss your case and learn about your legal rights. You may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages related to the defective product.

*******

The Ammons Law Firm represents clients nationwide in personal injury and wrongful death litigation.

Disclaimer: This post is not legal advice. Information contained in this blog was compiled from third-party sources or is the opinion of the author. Please inform us immediately if false or misleading information is contained in this post.