This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  

Affected Product

  • Product Names: Several IMRIS Neuro III-SV models:
    • Neuro III-SV iMRI System
    • iMRX System
    • iMRI 3T S
    • IMRIS iMRI 3T V
    • InVision 3T Operating Suite

What to Do  

This issue can only be identified by qualified personnel from Siemens Healthineers service organization. Siemens Healthineers is preparing an inspection and, if necessary, a correction that will resolve this potential issue.

If the error message shown in Figure 1 appears on your host computer, do not reboot the system. Please call your local Siemens Healthineers service organization.

  • The Magnet Stop is only intended for emergencies. Do not initiate a manual quench of the magnet unless there is an emergency.
  • Ensure all designated emergency exit routes remain unobstructed at all times and are properly marked. In particular, the exit from the examination room and/or operating room must be maintained at all times.

On October 13, 2025, IMPRIS Imaging Inc sent all affected customers an Urgent Medical Device Correction notice recommending the following actions:

  • Review the content of the Siemens communication included in the notice.
  • Confirm receipt of this notice with IMRIS using the Customer Acknowledgement Form.
  • Watch for an error message described in Siemens’ communication. If the error message (also shown in Figure 1) “Magnet Supervision: The average heater power is above the alarm threshold.
  • Please contact Siemens Healthineers Service” appears on your host computer, no further scans can be performed, and you are requested to:
    • Not reboot the system.
    • Remove the patient from the system.
    • Lock/secure all access to the scanning room with the system remaining energized at field.
    • Post a “DO NOT USE” notice on or near the device.
    • Make sure all relevant personnel are aware of this issue.
  • Call the Siemens Healthineers service organization at 1-800-888-7436
  • Ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein.
  • If this equipment is no longer in your possession, please forward this Customer Safety Advisory Notice to the new owner of this equipment.

Reason for Correction  

IMPRIS Imaging Inc is correcting IMRIS Neuro III-SV models due to the possibility of an ice blockage in the helium venting pipe.

This recall is a downstream recall of the class I recall for the Siemens Healthineers 3 Tesla MRI systems. All impacted IMPRIS MR units uses the same 3T magnet and venting system from Siemens that are under recall. In the event of a sudden loss of superconductivity, or magnet quench, helium gas may be unable to escape through designated venting paths, leading to pressure build-up within the helium containment system. This pressure build up could rupture the helium containment system, potentially resulting in a massive helium leak into the scanning room. Rupture of the helium containment system may also manifest as an explosion, with overpressure in the MRI room and debris expelled forcefully.

The use of affected product may cause serious adverse health consequences, including cold burns, asphyxiation, trauma, and death.  

There have been no reported injuries and no reports of death.  

Device Use

The IMRIS Neuro III-SV is a traditional MRI unit that has been suspended on an overhead rail system and is designed to operate inside an RF-shielded room to facilitate intra-operative and multi-room use. The IMRIS operating suites incorporate Siemens 3T magnet. The magnet is normally situated in a diagnostic room until imaging is requested. The system retains all standard diagnostic features of an MRI system in the diagnostic room. The room is separated from the intra-operative operating room by sliding doors that are part of the facility structure.

Contact Information  

Customers in the U.S. with questions about this recall should contact IMPRIS Imaging Inc customer support team at 1-866-475-0525 or customersupport@imris.com.

Additional FDA Resources:  

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.