Siemens Healthineers has announced corrective actions for its 3 Tesla MRI systems, addressing a potentially severe safety risk that may impact healthcare facilities using these devices. This alert is crucial for healthcare professionals, quality assurance teams, and regulatory bodies responsible for medical device compliance.
What changed?
On August 27, 2025, Siemens Healthineers issued an Urgent Medical Device Correction letter to inform customers of a significant issue involving ice blockages in the magnet venting systems of their 3 Tesla MRI systems. This blockage could disrupt helium gas venting in case of a magnet quench, causing a dangerous pressure build-up inside the helium containment system. If unresolved, the containment system could rupture, resulting in a sudden and forceful release of helium gas within the scanning room. Such incidents may lead to explosions, overpressure in the room, and debris projection.
The FDA categorizes this correction as the most serious type of recall, highlighting the potential for serious injury or death without appropriate intervention.
Who is affected?
The recall impacts 3 Tesla MRI systems manufactured by Siemens Healthineers, including their magnetic resonance diagnostic devices (MRDD) and combined MRDD and Positron Emission Tomography (PET) systems. These devices are used by trained healthcare professionals to detect and diagnose various diseases and disorders, including those affecting the head, body, and extremities.
As of August 29, 2025, Siemens Healthineers reported no injuries or deaths linked to this issue. However, users of affected devices are strongly advised to comply with safety instructions provided in the correction notice.
Why is this safety action critical?
If the error message stating, “Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Healthineers Service” appears on the host computer, immediate action is required. The presence of this error indicates that no further scans should be performed until corrective measures are completed.
Failure to address the issue could lead to severe health consequences, including asphyxiation, cold burns, trauma, or death due to the sudden release of helium into the scanning room. Siemens Healthineers emphasizes the importance of adhering to the safety steps outlined in their guidance.
Steps for healthcare facilities
- Do not reboot the system and immediately remove the patient from the scanner.
- Secure the room to prevent access, keeping the system energized at field.
- Place a “DO NOT USE” notice near the device to warn staff.
- Contact Siemens Healthineers’ service organization for assistance.
- Ensure emergency exit routes are unobstructed and clearly marked.
- Only initiate a magnet quench in case of an emergency, and ensure all personnel are informed of these instructions.
- Grant Siemens Healthineers’ representatives access to perform required inspections.
Users must comply with these recommendations to minimize risks while awaiting corrective inspection.
What is a UDI System?
A Unique Device Identifier (UDI) helps track medical devices from manufacturing to patient use. This system enhances adverse event reporting, enabling faster identification and correction of device-related problems.
Reporting guidelines
Healthcare professionals and consumers can report problems related to these devices using FDA’s MedWatch Safety Information and Adverse Event Reporting Program. This ensures critical issues are logged and improves safety oversight.
Conclusion
The corrective actions initiated by Siemens Healthineers aim to prevent serious health hazards associated with their 3 Tesla MRI systems. Healthcare facilities are urged to act immediately by following the manufacturer’s guidelines and reporting any adverse events to enhance patient and staff safety.
Disclaimer
This article is for informational purposes only and does not constitute legal, clinical, or regulatory advice. Always consult official regulatory documents and professional guidance for compliance matters.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/alert-siemens-healthineers-issues-correction-3-tesla-mri-systems