On January 11, 2026, the FDA published an urgent alert regarding a correction by Siemens Healthineers for certain 3 Tesla MRI systems. Health care facilities using these systems are strongly advised to review and comply with the recommended safety actions. This issue has significant implications for patient and staff safety, emphasizing the need for immediate attention from clinical, quality, and regulatory teams.
What changed?
Siemens Healthineers has identified a critical safety issue affecting their 3 Tesla MRI systems. Specifically, the magnet venting system in some devices may develop or already possess an ice blockage. In the event of a magnet quench—a sudden loss of a system’s superconductivity—helium gas might fail to vent as designed. This could lead to an increase in pressure inside the helium containment system, resulting in a potentially dangerous rupture or explosion.
This correction, issued in an Urgent Medical Device Correction letter dated August 27, 2025, applies to devices such as magnetic resonance diagnostic devices (MRDD) and mMR systems, which combine MRDD with Positron Emission Tomography (PET).
Who is affected?
The correction affects health care professionals and facilities utilizing Siemens Healthineers 3 Tesla MRI systems in the U.S. These systems provide critical imaging for identifying and diagnosing various medical conditions related to the head, body, or extremities. Inappropriate use or failure to address the reported issue can lead to serious risks, including cold burns, asphyxiation, physical trauma, and even death.
While there have been no serious injuries or fatalities reported thus far, timely action is essential to prevent potentially severe consequences.
What should affected facilities do?
Siemens Healthineers has provided detailed guidance to ensure patient and staff safety. If the error message “Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Healthineers Service” appears, facilities should take the following actions:
- Do not reboot the system.
- Remove any patient from the affected system.
- Secure and lock access to the scanning room, keeping the system energized at field.
- Post a visible “DO NOT USE” sign near the device.
- Contact your local Siemens Healthineers service organization at 1-800-888-7436 for further assistance.
Additionally, facilities must ensure that all emergency exit routes remain unblocked, accessible, and clearly labeled. Importantly, the Magnet Stop function must only be used in emergency situations to prevent accidental system quenching.
Inspection and compliance measures
Until inspections are completed under the guidance of the Siemens Healthineers service organization, facilities may continue using the system with heightened vigilance. All relevant personnel should be informed of this issue to ensure compliance with the specified safety measures. If the equipment has been transferred to another facility, the issued notice must be forwarded promptly to the new owner.
Facilities are also encouraged to report any adverse experiences or quality issues with these MRI systems to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Understanding the safety risk
The malfunction under scrutiny involves the magnet venting system. If obstructed by an ice blockage during a magnet quench, the helium gas typically expelled through designated pathways could build up pressure within the containment system. This scenario could lead to structural failure, causing a helium leak or even an explosion within the scanning room.
The associated risks include severe injury or fatalities resulting from cold burns, oxygen depletion (asphyxiation), trauma from overpressure or the release of debris, and other related hazards. Such risks underline the importance of inspection and correction of affected systems to ensure safe operation.
Conclusion
This situation highlights the importance of stringent safety measures in the use of advanced medical imaging systems. Health care professionals and facilities must adhere strictly to the safety protocols and cooperate fully with Siemens Healthineers to facilitate timely inspections and resolutions. These efforts are vital to safeguarding patient care and maintaining high standards in imaging practices.
Disclaimer
This article provides factual information based on the FDA’s official announcement and should not be construed as legal advice. Users of affected devices should directly follow the guidance provided by Siemens Healthineers and consult with regulatory or legal experts for compliance-related questions.
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/mri-system-correction-siemens-healthineers-issues-correction-3-tesla-mri-systems