Philips Azurion System Injury & Wrongful Death Lawsuit Lawyers

Dangerous Malfunctions in Philips Azurion Imaging Systems Prompt National Lawsuit Inquiries

Medical imaging systems are crucial in high-stakes procedures, especially those involving life-threatening conditions. The Philips Azurion System, widely used in hospitals and surgical suites across the country, was recently the subject of a serious recall announced by the U.S. Food and Drug Administration (FDA). The reason is a defect that causes a sudden loss of X-ray imaging mid-procedure—precisely when real-time imaging is most critical for guiding life-saving interventions.

This defect stems from a communication failure between the Azurion software and the system’s X-ray generator firmware. The results can be catastrophic. During delicate procedures such as treatment for acute ischemic stroke, life-threatening internal bleeding, or cardiac emergencies, any delay—even of seconds—can mean permanent injury or death.

Currently, there are more than 2,300 Philips Azurion systems in use in the United States and approximately 9,700 worldwide. If you or a loved one suffered injury or death during an interventional procedure where this system was used, it is possible that a sudden imaging failure caused or contributed to the harm. You may have grounds to pursue a lawsuit against the manufacturer for negligence, product liability, or wrongful death.

FDA Recall Confirms Serious Risks Linked to Philips Azurion Systems

The FDA’s Class 2 recall of the Philips Azurion System was officially posted on June 12, 2025. It followed internal reports and field data showing that the imaging system could abruptly stop displaying X-ray images during live procedures. According to the FDA’s alert, this issue poses a serious threat during complex or urgent medical interventions that depend on continuous imaging for safety and precision.

Philips itself acknowledged that this issue could result in delays to therapy and adverse health outcomes, including death if it occurs during procedures for:

• Acute ischemic stroke
• ST-segment elevation myocardial infarction (a serious heart attack)
• Emergency bleeding control
• Other life-threatening conditions

The malfunction is due to a software-to-hardware communication failure that disrupts the imaging functionality. Without real-time imaging, physicians lose their ability to accurately guide catheters, stents, or other surgical tools. For the patient, that delay can result in irreversible damage such as permanent brain injury, organ failure, or death.

Although Philips has issued device correction letters and is working on a software update, those measures may come too late for patients who have already suffered serious consequences. Hospitals and clinicians have been asked to retain instruction sheets in procedure rooms and report any incidents, but these interim steps do not undo the damage already caused.

What Makes the Azurion System Defect So Dangerous?

Interventional procedures depend on uninterrupted, real-time imaging. Physicians must see exactly where catheters, wires, and tools are being placed in the body. The Azurion system is designed to provide continuous X-ray imaging throughout these delicate operations. When the system fails mid-procedure, surgeons are forced to stop or proceed with limited information—either of which can lead to catastrophic results.

Even short disruptions in imaging can:

• Delay critical decision-making in the middle of an operation
• Prevent identification of complications such as ruptures or hemorrhage
• Lead to the misplacement of medical devices
• Cause tissue damage or unintended organ penetration
• Increase the likelihood of stroke or cardiac arrest
• Result in incomplete treatment or procedural abandonment

The most severe risk is that these failures occur during high-acuity, time-sensitive interventions—cases where every second counts. When imaging goes dark during a procedure designed to save a life, the outcome can be permanent disability or wrongful death.

Who May Be Eligible to File a Lawsuit?

Any patient who experienced harm during a procedure where a Philips Azurion System was used may be eligible to pursue legal action. This includes:

• Individuals who suffered a stroke, heart attack, or serious injury during a procedure where X-ray imaging was lost.
• Families who lost a loved one in a procedure involving Philips Azurion imaging equipment.
• Patients who experienced delayed emergency treatment, incomplete procedures, or neurological damage due to a paused intervention.

It is especially critical to investigate any sudden negative outcome during a surgery that used an Azurion system. Because imaging failure may not always be documented in post-op summaries, it often takes a legal investigation—supported by medical experts and hospital records—to uncover whether a software fault contributed to the outcome.

Our law firm is currently working with families across the country to evaluate claims and hold the manufacturer accountable for the harm caused by this dangerous defect.

Philips’ Responsibility and Legal Grounds for Compensation

Manufacturers of medical devices have a legal duty to ensure their products are safe and effective for their intended use. When they fail to do so, and that failure results in injury or death, they can be held liable under several legal theories, including:

• Product liability: If the Azurion system was defective in design, manufacturing, or instructions for use.
• Negligence: If the company failed to properly test, monitor, or respond to known risks.
• Failure to warn: If physicians and hospitals were not adequately informed of the dangers or interim risk-reduction steps.
• Wrongful death: If a patient’s death can be traced to the device malfunction.

In these cases, victims and their families may be entitled to recover compensation for:

• Medical expenses related to the injury or delayed procedure
• Future medical care and rehabilitation
• Pain and suffering
• Lost income or diminished earning capacity
• Funeral expenses and loss of companionship (in wrongful death cases)

The presence of an FDA recall strengthens the legal position of injured patients. It confirms that the product posed a real and recognized safety risk—and that harm could have been preventable.

What To Do If You Suspect a Philips Azurion Imaging Failure Caused Harm

If you or your loved one experienced serious complications during an interventional procedure and you suspect the imaging system failed, take the following steps:

1. Request a full copy of the surgical and hospital records. These documents may show what equipment was used and whether imaging was interrupted.
2. Ask the treating physician or hospital whether a Philips Azurion system was involved.
3. Document your injuries and medical history. Create a timeline of symptoms, treatments, and complications that followed the procedure.
4. Contact an experienced product liability attorney. Legal professionals can request maintenance logs, manufacturer records, and other evidence to support your claim.

Time is critical. Evidence must be preserved, and statutes of limitations apply. Waiting too long to act could jeopardize your ability to hold Philips accountable.

National Legal Representation for Medical Device Injury and Wrongful Death Claims

Parker Waichman LLP is a nationally recognized civil litigation law firm dedicated to representing individuals and families harmed by defective medical products. Our attorneys are actively investigating claims involving the Philips Azurion System across the United States.

We believe patients deserve to be protected from equipment failures—especially during life-saving procedures. If you or a loved one suffered severe harm or died during an operation where the Azurion imaging system was used, we may be able to help you pursue justice and financial compensation.

Our team includes legal and medical professionals who will investigate the facts of your case thoroughly and advocate for your rights every step of the way.

Contact Parker Waichman LLP For a Free Case Review

If you or a family member suffered severe injury or death during a procedure where a Philips Azurion imaging system was used, you may be entitled to compensation. This malfunctioning device has put countless lives at risk, and our law firm is standing by to hold the manufacturer accountable.

Call Parker Waichman LLP now at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation with an experienced product liability attorney. We are accepting Philips Azurion injury and wrongful death cases nationwide. Let us help you protect your rights and pursue the justice you deserve. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.