Philips Azurion Software Injury Lawsuit Lawyers  

Nearly 11,000 Philips Interventional Systems Reportedly Affected by Software Problems That Can Degrade Images or Stop Equipment Movement During Patient Procedures.

What Parker Waichman LLP Found

• Philips identified software problems that may cause image quality degradation or loss of geometry movements during interventional procedures.
• Potential consequences identified in safety documentation include delayed therapy, procedural complications, and inappropriate treatment.
• Patients undergoing urgent procedures for conditions such as acute ischemic stroke, serious myocardial ischemia, and life-threatening bleeding may face particular risk if treatment is interrupted.
• A recall alone does not establish an injury claim. A lawsuit investigation must connect the equipment malfunction to the patient’s actual harm.
• Patients with serious complications should preserve medical records and investigate the device model, software version, error logs, maintenance history, recall communications, and timing of any procedural interruption.

Patients who had cardiac, vascular, neurological, or other image-guided procedures with certain Philips Azurion systems may have faced a serious safety issue. A Class 2 recall for these systems highlights software problems that can lower image quality or stop equipment movement during use. These issues are serious, especially during a procedure. Interventional fluoroscopy gives doctors real-time images that are essential for guiding instruments, placing devices, identifying anatomy, and making treatment decisions.

Philips identified two software-related issues that can potentially result in delayed therapy, procedural complications, or inappropriate treatment. Regulatory safety information concerning the problem specifically identifies patients undergoing complex or urgent interventions for potentially life-threatening conditions as among those most at risk. These can include patients receiving emergency treatment for acute ischemic stroke, ST-segment elevation myocardial infarction, or life-threatening bleeding.

This recall matters because imaging or equipment problems can happen just when doctors need the system most. Patients on the table often do not know if a software issue occurs. If this leads to delayed treatment, a wrong procedure, injury, or worsening of the patient’s condition, figuring out what happened may require a close review of medical records, device logs, hospital notes, and recall documents.

Patients and families who think an injury happened during a procedure with an affected Philips Azurion system should know that a recall does not automatically mean there is a lawsuit. However, a recall can be important evidence when looking into whether a device problem caused an unexplained complication, delay, extra procedure, serious injury, or death.

What Is the Philips Azurion Interventional System?

Philips Azurion systems are advanced X-ray machines that help doctors see inside the body during diagnostic and treatment procedures. Unlike a regular X-ray, interventional fluoroscopy lets medical teams watch internal structures in real time and guide devices during the procedure.

These systems can be used in cardiovascular, vascular, neurovascular, and other minimally invasive interventions. During such procedures, physicians may be advancing catheters, guidewires, stents, balloons, or other instruments through the patient’s body while relying on imaging to understand exactly where those instruments are positioned.

That makes image quality essential. A physician needs to see what is occurring with sufficient clarity to make decisions safely and quickly. Equipment geometry is also important because the imaging equipment must be positioned appropriately relative to the patient and the part of the body being treated.

A malfunction does not necessarily mean a physician will make a mistake or that a patient will be injured. Medical professionals may recognize the problem, use alternative techniques, restart the system, or otherwise complete the procedure safely. The concern is what can happen when the malfunction occurs during a time-sensitive or particularly delicate portion of an intervention.

Regulatory materials addressing the software problem acknowledge that image degradation during a critical phase of a procedure could potentially contribute to procedural complications or inappropriate treatment. They also acknowledge that loss of movement could cause procedural complications or delay therapy.

For a critically ill patient, minutes can matter.

What Software Problems Led to the Philips Azurion Recall?

The current safety action concerns two principal problems: image quality degradation and loss of geometry movements.

The first issue can interfere with the quality of images available to medical professionals. When clinicians are performing an image-guided intervention, degraded images can interfere with their ability to visualize anatomy and accurately follow what is occurring inside the patient’s body.

The second problem concerns loss of geometry movements. Certain configurations can experience a loss of the equipment movements needed to properly position the imaging system. Health Canada similarly identifies the affected issue as involving image quality degradation and loss of geometry movements, with the movement issue applying to systems equipped with an AD7X table.

Philips provided healthcare facilities with procedures intended to restore functionality when either problem occurs. For degraded image quality, the company instructed users to perform a cold restart as soon as clinically feasible. Regulatory documentation states that a cold restart can take as long as six minutes before all system functionality becomes available again.

For loss of geometry movements, users were instructed to perform a geometry restart involving the emergency stop and power controls. That process may take approximately two minutes.

Six minutes may sound brief outside a hospital procedure room. During treatment of an acute stroke, severe cardiovascular event, or uncontrolled bleeding, however, any interruption can become clinically significant depending upon the patient’s condition and the stage of the procedure.

The central question in an injury investigation is therefore not merely whether the machine malfunctioned. It is whether the malfunction affected what happened to the patient.

Why Degraded Fluoroscopy Images Can Create a Serious Patient Safety Risk

Interventional medicine depends heavily upon visualization. Physicians performing minimally invasive procedures often cannot directly see the structures being treated. They instead use fluoroscopic images and other imaging technologies to guide instruments through the body.

When image quality deteriorates, a physician may lose some of the visual information needed to proceed confidently.

Depending on the procedure, clinicians may be attempting to identify blood vessels, navigate a catheter, position a stent, treat an obstruction, control bleeding, or perform another highly precise intervention. If the image becomes difficult to interpret during a critical step, the physician may need to stop, wait for the equipment to recover, switch techniques, or make other clinical decisions.

Philips’ safety documentation recognizes several possible consequences. Image quality degradation may contribute to delayed therapy, procedural complications, or inappropriate treatment. Patients undergoing complex and urgent procedures for potentially life-threatening conditions are specifically identified as being most at risk.

This distinction matters legally.

A patient generally does not have a viable injury claim simply because an affected machine was present in the room. There ordinarily must be evidence connecting the product problem to an actual injury or legally compensable loss.

Suppose, however, that imaging unexpectedly degraded during a stroke intervention, causing the procedure to be interrupted while the system was restarted. If the patient’s condition deteriorated during that interruption and physicians documented that the equipment problem delayed treatment, those facts could warrant a much closer legal investigation.

Similarly, if degraded imaging contributed to incorrect device placement, vascular damage, additional surgery, prolonged hospitalization, or another complication, attorneys may investigate whether the medical device malfunction was a substantial factor in causing the injury.

Loss of Geometry Movements May Interrupt Critical Procedures

The geometry movement problem presents a different type of danger.

Interventional imaging equipment must be positioned relative to the patient so clinicians can obtain the views needed to perform a procedure. If motorized geometry movements become unavailable, physicians may be unable to reposition the equipment as expected.

Philips’ safety documentation states that loss of movement during clinical use may potentially contribute to procedural complications or delayed therapy. The company again identifies patients undergoing urgent interventions for potentially life-threatening conditions as the population at greatest risk. The documentation further recognizes that treatment delays in critically ill patients can contribute to deterioration and potentially death, although Philips characterized the estimated probability of serious adverse health outcomes as improbable.

That probability assessment should not be confused with an assessment of an individual patient’s case.

A rare malfunction can still have devastating consequences for the person who experiences it.

If a patient suffers a stroke-related disability, cardiac injury, neurological damage, hemorrhage, vascular injury, or death after an equipment malfunction interrupted a procedure, the patient’s records should be examined carefully to determine the sequence of events.

Patients Undergoing Emergency Procedures May Face the Greatest Injuries

The circumstances under which a malfunction occurs can be just as important as the malfunction itself.

An equipment interruption during a scheduled, non-emergency procedure involving a medically stable patient may have very different consequences from the same interruption during treatment of an acute stroke, major heart attack, or life-threatening hemorrhage.

Philips’ safety materials specifically reference acute ischemic stroke, ST-segment elevation myocardial ischemia, and life-threatening bleeding as examples of urgent conditions in which affected patients could face greater risks.

An acute ischemic stroke can involve blockage of blood flow to part of the brain. Certain patients may undergo endovascular procedures in which clinicians attempt to remove or otherwise treat the obstruction. Delays can be consequential because brain tissue deprived of blood and oxygen can suffer irreversible injury.

The same general concern applies to serious cardiovascular emergencies. When blood supply to heart muscle is compromised, timely restoration of circulation can be crucial. An equipment interruption occurring while clinicians are attempting to diagnose or treat the problem may become an important part of the patient’s medical history.

Life-threatening bleeding creates another obvious concern. A patient who is actively hemorrhaging may deteriorate rapidly. If physicians are using interventional techniques to locate or control the source of bleeding, imaging equipment problems could potentially interfere with treatment.

None of this establishes that a recalled Azurion system caused an individual patient’s poor outcome. It does demonstrate why an unexplained interruption during one of these procedures deserves investigation.

What Injuries Could Potentially Be Associated With an Interventional Imaging System Malfunction?

The injuries potentially associated with a malfunction depend heavily upon the patient’s underlying medical condition and the procedure being performed.

Some injuries may result directly from a procedural complication. Others may occur because necessary treatment was delayed. Still others could arise if degraded imaging contributes to an incorrect clinical decision or inaccurate positioning of an instrument or device.

Potential injuries that could warrant investigation include neurological injury following delayed stroke treatment, worsening cardiac damage, vascular injuries, uncontrolled bleeding, organ damage, complications requiring emergency surgery, prolonged hospitalization, permanent disability, and death.

A patient could also experience significant additional medical expenses if a malfunction results in a procedure being abandoned or repeated. Additional imaging, corrective procedures, rehabilitation, home healthcare, prescription medications, and long-term assistance may all become necessary after a severe complication.

A lawsuit should therefore examine the entire medical course rather than focusing solely on the moment the equipment malfunctioned.

Evidence That May Be Important in a Philips Azurion Injury Lawsuit

Evidence can disappear, be overwritten, or become more difficult to obtain as time passes. A careful investigation may seek information beyond the ordinary patient chart.

Potentially important evidence can include:

• Complete hospital and physician medical records;
• Operative and interventional procedure reports;
• Nursing and anesthesia records;
• Fluoroscopy and imaging records;
• Device model and serial-number information;
• Software version information;
• System error and event logs;
• Equipment maintenance and service records;
• Philips correction and recall communications;
• Hospital communications regarding the software problem;
• Records showing when corrective software was installed;
• Documentation of procedure delays, interruptions, or equipment restarts; and
• Records of additional treatment required after the complication.

The procedure report can be especially important because clinicians may document unexpected equipment failures, delays, changes in technique, aborted procedures, or difficulties obtaining adequate images.

Device logs may provide a second layer of evidence. If preserved and available, electronic information may help establish precisely when an error occurred and how long functionality was interrupted.

Compensation That May Be Available After a Serious Medical Device Injury

When a defective medical device causes injury, compensation may extend well beyond the cost of the original procedure.

A patient with permanent neurological or cardiovascular damage may require years of treatment. Severe neurological injuries can affect speech, cognition, mobility, independence, employment, and the ability to perform everyday activities. Some patients require rehabilitation, nursing assistance, adaptive equipment, home modifications, and ongoing medical supervision.

Depending on applicable state law and the facts of the case, recoverable damages may potentially include past and future medical expenses, lost wages, diminished earning capacity, pain and suffering, disability, loss of normal life, rehabilitation expenses, and other economic and non-economic losses.

If an alleged medical device defect contributes to a patient’s death, surviving family members or the estate may potentially pursue wrongful death and survival claims. The damages available in those cases vary significantly by state.

Because statutes of limitation also vary, families should not assume they have an unlimited amount of time simply because a recall was recently announced.

Philips Azurion Recall Lawsuit FAQs

Who may qualify to file a Philips Azurion lawsuit?

A patient may have grounds for further investigation if an affected Philips Azurion system was used during an interventional procedure and a software or equipment malfunction caused or contributed to a serious injury. Particularly important circumstances may include unexpected procedure delays, degraded imaging, inability to reposition equipment, an emergency restart, an aborted procedure, incorrect treatment, additional surgery, permanent neurological or cardiovascular injury, or death. Merely having undergone a procedure involving an affected Azurion system does not automatically establish a claim. Attorneys must determine whether the particular device was affected, whether a malfunction actually occurred, and whether that malfunction caused additional harm.

How can I find out whether a Philips Azurion system was used during my procedure?

The information may appear in operative reports, interventional radiology records, cardiac catheterization records, imaging documentation, or other portions of the hospital chart. If the records provided to the patient do not identify the equipment, additional records may need to be requested from the hospital. A legal investigation can potentially seek device model and serial numbers, software versions, maintenance records, system logs, service histories, and documentation showing whether the equipment was included in the corrective action.

Can a treatment delay caused by recalled equipment support a lawsuit?

Potentially. The critical issue is whether the delay caused additional injury. Philips’ safety documentation recognizes that the software problems can potentially contribute to delayed therapy and that delays involving critically ill patients can worsen an already serious condition. A claim may require medical evidence establishing what likely would have happened without the delay compared with what actually occurred. This causation analysis can become particularly important in stroke, cardiac, hemorrhage, and other time-sensitive cases.

What damages may be recoverable in a Philips Azurion injury lawsuit?

Compensation depends on the injury and applicable state law. Potential damages can include medical expenses, additional hospitalization, rehabilitation costs, future medical care, lost income, reduced earning capacity, pain and suffering, permanent disability, and other losses. When an alleged medical device defect contributes to death, eligible survivors or the estate may potentially pursue wrongful death or survival damages. Because these laws differ substantially among states, each case must be evaluated individually.

Is there a deadline for filing a medical device lawsuit?

Yes. Every state imposes deadlines that can limit the time available to pursue product liability, negligence, wrongful death, and other injury claims. The applicable deadline may depend on where the injury occurred, when the injury was discovered, when its potential cause reasonably could have been discovered, and other circumstances. Patients should not assume that the date of the FDA recall determines their filing deadline. Waiting can also make device logs, hospital records, and other technical evidence more difficult to preserve.

Contact Parker Waichman LLP About a Philips Azurion Recall Lawsuit

Patients enter an interventional procedure expecting the medical equipment being used to function as intended. When an imaging system loses image quality or necessary movement during a critical procedure, the patient may never know that an equipment problem occurred unless someone investigates the records.

If you or a family member suffered a serious injury, unexpected deterioration, additional surgery, permanent disability, or death following a procedure involving a Philips Azurion interventional system, Parker Waichman LLP can investigate whether recalled equipment may have played a role.

A medical device case may require more than reviewing ordinary medical records. Attorneys may need to identify the exact equipment used, determine its software version, obtain maintenance and service histories, investigate system errors, review recall communications, and work through the medical timeline to determine whether a malfunction delayed or altered treatment.

Parker Waichman LLP represents injured patients and families nationwide in product liability and serious personal injury matters. There is no charge for an initial consultation, and potential clients can learn about their legal options without making a commitment to file a lawsuit.

Call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation about a potential Philips Azurion recall lawsuit. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.