Defective Software Linked to Patient Injuries and Deaths Sparks FDA Class I Recall
The U.S. Food and Drug Administration (FDA) has issued a Class I recall, its most serious designation, for the software used in Philips' Mobile Cardiac Outpatient Telemetry (MCOT) devices following a critical failure that resulted in high-risk heart events going unreported. This recall, announced on December 18, 2024, affects patients monitored with the MCOT system between July 2022 and July 2024.
Philips' MCOT devices are used for remote heart monitoring, collecting electrocardiogram (ECG) data to detect potentially life-threatening cardiac events. The recall was prompted after reports revealed the software had failed to transmit certain high-risk cardiac events to trained cardiology technicians, leaving serious health events undetected and untreated. As a result of this malfunction, the FDA has confirmed 109 patient injuries and at least two patient deaths.
Details of the Philips MCOT Recall
The issue stemmed from a software failure preventing the transmission of critical heart data, including events such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and advanced atrioventricular (AV) block. These conditions can lead to severe complications, including stroke, heart failure, and sudden cardiac arrest, if left untreated.
Philips and its subsidiary, Braemar Manufacturing, notified all impacted customers through an Urgent Medical Device Correction issued in December 2024. The notice provided instructions for reviewing affected patient data and determining whether any reprocessing of the data was necessary. Healthcare providers were directed to identify and notify patients who may have been impacted, as Philips stated it would not be contacting patients directly regarding the issue.
While the FDA issued the recall as a Class I event due to the serious risk posed, the MCOT devices themselves are not being physically removed from the market. Instead, Philips has focused on correcting the software issue while allowing continued use of the devices. The company emphasized that the issue had been identified and resolved, with corrective measures in place to prevent further failures.
How the Defective Philips Heart Monitors Harmed Patients
The Philips MCOT software failure has had a profound impact on patient safety. Remote cardiac monitoring devices like the MCOT are often prescribed for patients with a high risk of heart arrhythmias or those recovering from cardiac procedures. These devices continuously track a patient’s heart rhythm, alerting medical professionals of irregular activity that could indicate a life-threatening event.
Due to the software defect, significant cardiac events went undetected, delaying critical medical intervention. The failure to relay essential data resulted in numerous health complications, including 109 reported patient injuries and two confirmed deaths. Patients suffering from undetected arrhythmias or heart blockages could experience severe outcomes such as stroke, heart attack, or sudden cardiac arrest.
For some patients, the delay in receiving proper care may have led to the worsening of underlying cardiac conditions, requiring more invasive treatments or long-term medical care. Family members of deceased patients have been left searching for answers, with many facing not only emotional distress but also significant financial burdens from medical expenses and funeral costs.
Legal Rights for Victims Affected by the Philips MCOT Recall
Patients who suffered harm due to the Philips MCOT heart monitor software failure may have the right to pursue compensation through a product liability lawsuit. Product liability laws hold manufacturers accountable when their products cause injury due to design defects, manufacturing issues, or a failure to warn consumers about risks.
In this case, Philips and its subsidiary, Braemar Manufacturing, may be held responsible for failing to ensure the proper functioning of critical medical software used in heart monitoring. The failure to transmit high-risk ECG data as intended led to delayed medical intervention, injuries, and fatalities, creating a legal basis for victims and their families to seek justice.
Potential grounds for a lawsuit include:
- Negligence: Philips failed to ensure the proper functioning of the MCOT software despite the life-threatening risks associated with undetected heart events.
- Failure to Warn: Philips did not adequately inform patients of the software failure or directly contact affected individuals, placing the burden on healthcare providers.
- Product Defect: The software failure in a life-saving medical device raises clear concerns of a defective product, which directly endangered patients.
The Lawsuit Process and Why Legal Representation Matters
Filing a product liability lawsuit for medical device failures involves several critical steps to ensure victims receive the compensation they deserve. The process generally begins with the identification of the defective product, followed by collecting evidence to support the claim of harm caused by the software failure.
The initial phase involves gathering medical records, documentation of the device's use, and evidence of harm directly resulting from the defective product. Plaintiffs will need to demonstrate how the MCOT failure contributed to their health complications or the loss of a loved one.
A formal legal complaint is then filed against Philips, outlining the allegations of negligence and product defect. The discovery phase follows, where both parties exchange evidence and expert testimony to establish the link between the software failure and the resulting harm.
Settlements are often negotiated during the pre-trial phase, but if a fair agreement cannot be reached, the case proceeds to trial. At trial, both sides present their arguments, and a judge or jury determines whether the defendant is liable for damages.
An experienced attorney is essential throughout this process. Product liability cases involving medical devices often require specialized legal knowledge and expert witnesses to establish a strong case. Philips is a multinational corporation with vast legal resources, making it critical for victims to have dedicated legal representation to fight for fair compensation.
Damages Victims May Recover in a Product Liability Lawsuit
Victims harmed by the Philips MCOT recall may be entitled to pursue various damages, including:
- Medical Expenses: Coverage for treatments, hospital stays, and medical interventions required due to delayed care.
- Pain and Suffering: Compensation for physical pain, emotional trauma, and diminished quality of life.
- Lost Wages: Reimbursement for income lost during treatment or recovery.
- Wrongful Death Damages: Families who lost a loved one may seek compensation for funeral expenses, loss of companionship, and financial support.
- Punitive Damages: In cases of severe negligence, punitive damages may be awarded to deter similar corporate misconduct in the future.
If you or a loved one has suffered harm due to the Philips heart monitor software failure, you may be entitled to significant compensation. The national product injury law firm Parker Waichman LLP is committed to holding negligent manufacturers accountable and protecting the rights of injured patients.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free, no-obligation consultation. Let our legal team help you fight for the justice and financial recovery you deserve. Regardless of your location or where your injury occurred, our national Philips heart monitor software failure law firm is ready to assist you.
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