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U.S. Department of Health and Human Services

Class 1 Device Recall IMRIS Operating Suite

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 Class 1 Device Recall IMRIS Operating Suitesee related information
Date Initiated by FirmSeptember 30, 2025
Date PostedOctober 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0163-2026
Recall Event ID 97750
510(K)NumberK083137 K101813 K133692 K212367 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductIMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Code Information IMRIS Part Number(s): 120823-000, UDI/DI 00857534006745
Recalling Firm/
Manufacturer		 IMPRIS Imaging Inc
1230 Chaska Creek Way Ste 100
Chaska MN 55318-2707
For Additional Information Contact
763-203-6300
Manufacturer Reason
for Recall		There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
FDA Determined
Cause 2		Under Investigation by firm
ActionImris issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 9/30/2025 via email. The notice explained the issue, the risk to health, and provided the following information: "If the error message, "Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Service." appears, DO NOT REBOOT THE SYSTEM. Please call your local Siemens Healthineers service organization. Grant access to the system so that the inspection can be carried out as directed by Siemens Healthineers service organization." "Please immediately instruct your personnel accordingly, and please contact our customer support team via our service line at 1-866-475-0525 or e-mail at customersupport@imris.com if you have any questions or concerns. Please keep this information until the corrective measures have been finalized." This notice included a copy of the Siemens Healthineers Urgent Medical Device Correction notice.
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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