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IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX… recallZ-0161-2026 · IMPRIS Imaging Inc · initiated Sep 30, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from IMPRIS Imaging Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

Imris 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 [email protected] 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.

Recall details

Recall number
Z-0161-2026
Status
Open, Classified
Initiated by the company
Sep 30, 2025
Posted by the FDA
Oct 28, 2025
Recalling firm
IMPRIS Imaging Inc
Product code
LNH
FDA submissions
K083137, K101813, K133692, K212367
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.

Product description

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

Code information (models, lots, serial numbers)

IMRIS Part Number(s): 105118-000, UDI/DI None predates UDI; 105118-001, UDI/DI None predates UDI; 105117-003, UDI/DI None predates UDI; 105117-004, UDI/DI None predates UDI; 105048-000, UDI/DI None predates UDI; 105048-001, UDI/DI None predates UDI; 105103-001, UDI/DI None predates UDI; 105071-004, UDI/DI None predates UDI; 105824-000, UDI/DI 00857534006189; 105828-000, UDI/DI 00857534006165; 116189-000, UDI/DI 00857534006202; 118396-000, UDI/DI 00857534006196.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K083137, K101813, K133692, K212367 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97750).

Sources and updates

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