Z-0161-2026Class I

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

Name: Z-0161-2026 IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Creator: IMPRIS Imaging Inc
Published: 2025-09-30
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2025-09-30 / Open, Classified

FDA source

IMPRIS Imaging Inc began a recall of IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio on 2025-09-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0161-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-09-30
Posted: 2025-10-28
Recalling firm: IMRIS Imaging, Inc.
Product: IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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 root cause: Under Investigation by firm
Action: 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.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0161-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0161-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-28
Z-0162-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-28
Z-0163-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-28
Z-0164-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-28

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)