On October 13, 2025, IMPRIS Imaging Inc. initiated an urgent correction notice for its IMRIS Neuro III-SV models in response to identified safety risks. The correction addresses a critical defect in the helium venting system, which poses life-threatening hazards if not resolved. This notification, classified by the FDA as a Class I recall, highlights the highest level of severity in medical device corrections.
Affected Devices and Risks
The correction impacts several IMRIS Neuro III-SV models, including:
- Neuro III-SV iMRI System
- iMRX System
- iMRI 3T S
- IMRIS iMRI 3T V
- InVision 3T Operating Suite
At the root of the issue is the helium venting system in the Siemens 3 Tesla (3T) MRI magnet incorporated into these products. An identified flaw causes a potential ice blockage in the helium venting pipe, which may prevent helium gas from escaping appropriately in the event of a magnet quench or sudden loss of superconductivity. Without proper venting, a dangerous pressure buildup can occur, resulting in a ruptured helium containment system. This can lead to hazardous outcomes such as suffocation, cold burns, trauma, or even death, as well as the potential for explosions with flying debris inside the MRI suite.
Though no injuries or deaths have been reported to date, the risks are significant, and immediate action is required to prevent adverse outcomes while the systems are corrected.
Who Should Act?
This correction primarily concerns healthcare providers, imaging departments, and regulatory teams operating affected units. Providers must remain alert and take steps to ensure patient and operator safety while awaiting device inspection and corrective servicing from Siemens Healthineers or IMPRIS Imaging Inc.
Recommendations for Device Users
IMPRIS Imaging Inc. advises users to follow these safety measures:
- If the error message “Magnet Supervision: The average heater power is above the alarm threshold” appears on the system, do not reboot the MRI unit.
- Immediately remove any patient undergoing imaging and cease further scans.
- Secure access to the scanning room and post a “DO NOT USE” notice near the device to prevent unauthorized entry or use.
- Contact Siemens Healthineers service organization at 1-800-888-7436 for further assistance.
Additionally, all emergency exit routes within MRI and operating rooms should remain unobstructed and clearly marked to enable swift evacuation if necessary. The use of the magnet’s manual quench feature is designated strictly for emergencies and should not be activated under normal conditions.
Next Steps for Institutions
Healthcare facilities in possession of affected IMRIS Neuro III-SV devices are encouraged to submit the Customer Acknowledgement Form included in the correction notice to confirm receipt of the instructions. This validates compliance with the corrective actions recommended. Facility managers should also disseminate this safety information to all relevant personnel.
If the equipment has been sold or transferred, the current owner should be notified promptly. IMPRIS also requests that users review Siemens’ communication and stay vigilant for error messages indicative of the helium venting issue.
Manufacturer’s Commitment to Safety
IMPRIS Imaging Inc., in collaboration with Siemens Healthineers, has prioritized resolving this technical deficiency to ensure ongoing safety and system performance. Inspections and potential corrections are being planned by qualified Siemens Healthineers service professionals, who will work directly with affected users to mitigate risks effectively.
Conclusion and Actionable Steps
Healthcare professionals operating IMRIS Neuro III-SV devices must act immediately to safeguard against the risks outlined in this correction notice. Compliance with the manufacturer’s recommendations and timely reporting of issues will ensure patient and provider safety while corrective actions are implemented. Stay proactive by maintaining clear communication with IMPRIS and Siemens Healthineers for updates on the inspection and corrective process.
Disclaimer
This article is for informational purposes only and does not constitute legal or regulatory advice. Always refer to official sources and consult with the appropriate regulatory bodies for compliance-related matters.