Siemens Magnetom Systems Pose Deadly Risk Due to Helium Ventilation Failure

Hundreds of Siemens MRI Machines Recalled After Reports of Pressure Build-Up and Potentially Fatal Helium Leaks During Quench Events

The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall, the agency’s most urgent safety classification, affecting hundreds of Siemens Healthineers MRI machines. The recall targets nine models from the Magnetom series, which are widely used across hospitals, outpatient imaging centers, and diagnostic clinics throughout the United States and abroad.

This recall stems from a potentially life-threatening ventilation failure discovered in these MRI units. The defect could cause pressure to build up in the helium containment system, especially during a “quench”—a sudden loss of superconductivity in the magnet system. In a worst-case scenario, the containment vessel may rupture, releasing helium gas into the MRI room, which can lead to suffocation, structural damage, or even death.

The danger is not hypothetical. This Class 1 designation means the risk of “serious adverse health consequences or death” is real if the problem goes uncorrected. Siemens Healthineers began notifying its customers by letter on August 28, 2025, advising medical providers to stop rebooting affected machines and await on-site inspection by trained personnel.

Understanding the MRI Quench and Helium Safety Risks

An MRI machine’s magnet system operates using liquid helium, which keeps superconducting magnets at extremely low temperatures. In rare cases, an event known as a quench can occur—where the superconducting state is lost, and the helium rapidly converts into gas. The system is designed to vent this helium safely outside the building.

The FDA’s warning reveals that some Siemens Magnetom MRI machines may fail to release helium through proper venting channels, resulting in pressure buildup. When this pressure builds beyond safety limits, the helium containment vessel could rupture, forcing helium gas into the scanning room.

Why is this dangerous?

• Asphyxiation Risk: Helium displaces oxygen. A large helium release in an enclosed space can lead to unconsciousness or death within minutes.
• Overpressure Events: The structural failure of the containment system can result in flying debris or injuries from physical damage.
• Fire Suppression System Triggers: The force of helium discharge could set off emergency systems, creating panic or additional risks for patients and staff.
• Patient Impact: A patient inside the MRI bore during a quench is at greater risk due to immobility and close proximity to the magnet housing.

These risks are not theoretical, which is why the FDA classified this recall with its highest urgency.

Which MRI Systems Are Affected by the Recall?

The issue affects nine different models from the Siemens Magnetom series, which are widely deployed across the globe. These systems are used in outpatient clinics, hospitals, and even mobile imaging centers. While Siemens has not publicly listed every individual model by serial number, it has begun direct outreach to known facilities housing the affected machines.

The impacted models fall within the Magnetom series, a line known for its wide bore and 1.5T and 3.0T imaging capabilities. These machines are commonly used for neuroimaging, musculoskeletal exams, and cancer screenings. As a result, this safety issue could affect thousands of patients undergoing routine diagnostics.

If a facility has received a safety notice, they are required to:

• Post the safety letter in a visible area for all MRI operators.
• Stop any attempts to reboot the MRI system.
• Await a trained Siemens representative to conduct system inspections and, if needed, perform corrective action.

Actions Taken by Siemens Healthineers

Siemens Healthineers acknowledged the issue in letters dated August 28, 2025. According to the company’s statement, qualified service representatives will be dispatched to inspect the affected MRI systems and perform necessary repairs or updates to prevent pressure buildup in the helium venting system.

The manufacturer has also instructed facilities to ensure the safety advisory is visible to all personnel involved in operating the MRI units. Operators are being told not to reboot the systems independently, as doing so could trigger the quench sequence improperly and heighten the risk of injury.

In the meantime, Siemens is actively investigating the root cause of the venting failure and working with the FDA to monitor and document any further complications.

Why This Recall Matters for Patients and Facility Operators

MRI scans are a common part of modern medical diagnostics. Patients routinely trust that their imaging appointments are both accurate and safe. This recall highlights a serious breach in equipment safety standards that could affect thousands of people—from patients undergoing a routine scan to technicians working in the scanning room.

Patients who may be at risk include:

• Individuals who were inside a Magnetom MRI system during a quench.
• Individuals experiencing respiratory symptoms or unexplained medical emergencies shortly after an MRI scan.
• Family members of individuals who died under unclear circumstances during or following an MRI procedure.

Facilities using the recalled units are not just facing safety concerns—they may also face liability for failing to take proper precautions or notify patients of potential harm.

Legal Implications of the MRI Recall

The FDA’s Class 1 recall means that Siemens MRI systems were potentially dangerous in a way that could cause severe injury or death. That creates a legal window for affected patients or their families to file product liability lawsuits or medical facility negligence claims, depending on the circumstances of their injury.

Potential legal claims may include:

• Product Liability: If the MRI unit malfunctioned during a scan and caused injury due to a flawed helium venting system, a legal claim can be brought against Siemens.
• Medical Malpractice or Premises Liability: If a hospital or clinic continued using a recalled system without warning or ignored Siemens’ safety instructions, they could be held responsible.
• Wrongful Death: Families of patients who died during or after a quench event may be eligible to pursue compensation.

Medical device manufacturers have a legal responsibility to ensure their products are safe for use. When defects are found, timely and effective action is critical. The combination of a high-powered magnet, enclosed space, and volatile gas makes this a high-stakes recall, with significant legal and financial consequences.

Who May Be Eligible to File a Lawsuit?

If you or a loved one experienced any of the following, you may have a claim:

• Respiratory distress during or after an MRI procedure.
• An unexplained injury or death in an MRI suite.
• Medical complications that occurred shortly after undergoing a Siemens Magnetom MRI scan.
• Staff members are exposed to helium gas or pressure incidents during MRI operation.

Even if the incident occurred weeks or months ago, facilities may not have disclosed the danger. A thorough review of your medical records and the equipment used is essential.

Siemens Magnetom MRI Recall Lawsuit FAQs

What is a Class 1 recall?
A Class 1 recall is the most serious type issued by the FDA. It means the product poses a reasonable probability of causing serious health problems or death if the issue is not corrected.

Why are Siemens MRI machines being recalled?
The recall affects nine Siemens Magnetom MRI systems. These machines may have defective helium venting systems that can fail during a quench, causing pressure buildup and potentially releasing helium gas into the scanning room.

What happens if helium escapes into an MRI room?
Helium displaces oxygen. In enclosed spaces, a large helium leak can cause asphyxiation, loss of consciousness, or death. Pressure buildup can also lead to structural damage or equipment rupture.

Am I at risk if I had an MRI recently?
The risk is primarily during a quench event. If your scan was uneventful, you may not be affected. However, if you experienced respiratory issues, dizziness, or medical complications after an MRI, legal consultation is advised.

Can I sue Siemens or the hospital?
Yes. If you were injured due to a faulty MRI system or a facility ignored safety warnings, you may be eligible for compensation. This could include medical bills, lost wages, and pain and suffering.

How do I know if my MRI was performed on a recalled machine?
Your medical provider can confirm the equipment model used. A legal team can assist in requesting those records and determining whether your scan involved a recalled unit.

What kind of lawyer handles these cases?
A personal injury law firm with national experience in medical device recalls can help you determine your rights and build a case.

Contact Parker Waichman LLP For A Free Case Review

If you or someone you love experienced unexpected medical complications during or after an MRI scan, you may have a legal claim related to the Siemens Magnetom MRI recall. Parker Waichman LLP is a national personal injury law firm investigating cases involving this dangerous equipment failure.

Our attorneys are actively reviewing claims involving oxygen deprivation, sudden respiratory failure, wrongful death, and other complications linked to faulty MRI systems.

Call 1-800-YOUR-LAWYER (1-800-968-7529) now for your free consultation. There is no cost unless we win your case. Let us help you protect your rights and hold those responsible accountable.