IMRIS iMRI 3T V 120823-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00857534006745), received between Jun 20, 2023 and Mar 19, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K212367); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 30, 2025Class IOpen, Classified

   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.

   Z-0163-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Mechanical Jam

  THE MAGNET MOVER EXPERIENCED A MECHANICAL MALFUNCTION CAUSING AN UNEXPECTED DOWNTIME CONDITION WITH A PATIENT UNDER ANESTHESIA FOR MORE THAN ONE HOUR, LEADING TO AN EXTENDED PROCEDURAL DELAY. PER THE SITE, THE PATIENT REMAINED STABLE, AND NO ADVERSE EVENTS OR UNANTICIPATED PATIENT OUTCOMES WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED, AND THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639926 ↗
• MalfunctionMar 19, 2026Mechanical Jam

  THE MAGNET MOVER EXPERIENCED A MECHANICAL MALFUNCTION CAUSING AN UNEXPECTED DOWNTIME CONDITION WITH A PATIENT UNDER ANESTHESIA FOR MORE THAN ONE HOUR, LEADING TO AN EXTENDED PROCEDURAL DELAY. PER THE SITE, THE PATIENT REMAINED STABLE, AND NO ADVERSE EVENTS OR UNANTICIPATED PATIENT OUTCOMES WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED, AND THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT AS A RESULT OF THE ISSUE. AFTER THE INITIAL MALFUNCTION WAS CORRECTED, A SEPARATE EVENT RENDERED THE MR SCANNER FULLY INOPERABLE, CAUSING MORE THAN ONE HOUR OF UNPLANNED DOWNTIME WHILE THE PATIENT REMAINED UNDER ANESTHESIA. THE CUSTOMER SERVICE ENGINEER WAS CONTACTED AND RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED, AND THE END USER REPORTED NO SERIOUS INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639914 ↗
• MalfunctionSep 6, 2024Circuit Failure; Connection Problem; Mechanical Jam; Circuit Failure; Connection Problem; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE INTRAOPERATIVE SLIDING DOORS (RF SHIELDING DOORS) WOULD NOT OPEN DURING A CRANIOTOMY FOR BRAIN TUMOR REMOVAL. AN INTRAOPERATIVE MRI SCAN WAS ORDERED TO DETERMINE EXTENT OF DEBULKING AND WHETHER RESIDUAL TUMOR REMAINED. THE OPEN-DOOR BUTTON WAS NOT ENABLED TO ALLOW USER TO OPEN THE INTRAOPERATIVE DOORS AND ADVANCE THE MRI MAGNET AS THE STATUS ON THE CONTROL PANEL WAS STILL SENSING AN OPEN OR ENTRY DOOR. THE EMERGENCY OVERRIDE BUTTON WAS PRESSED AND DID NOT RESOLVE THE ISSUE TO ALLOW OTHER DOORS TO OPEN. INTRAOPERATIVE IMAGES WERE NOT OBTAINED AND SURGERY RESUMED TO CLOSE THE SKULL. THE PATIENT HAD POSTOPERATIVE IMAGING IN THE DIAGNOSTIC ROOM WHICH REVEALED RESIDUAL TUMOR. IT WAS REPORTED THE CARE OF THE PATIENT (MEDS, MONITORING) WAS NOT IMPACTED OTHER THAN THE DELAY OF 30 MINUTES WHICH DID NOT CAUSE HARM TO THE PATIENT. IT WAS ALSO REPORTED FURTHER RESECTION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163871 ↗
• MalfunctionMay 24, 2024Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

  THE CUSTOMER REPORTED THAT DURING INTRA-OPERATIVE IMAGING IN THE OPERATING ROOM, A MAJOR BROADBAND RADIOFREQUENCY ARTIFACT PRESENTED DURING MR SCANNING AFTER THE MAGNET WAS ADVANCED TO IMAGING LOCATION IN THE OPERATING ROOM. THE RF NOISE PREVENTED THE DIAGNOSTIC IMAGES FROM BEING CLINICALLY USEFUL. THE PATIENT WAS TAKEN OUT OF THE SKULL PINS AND TRANSPORTED TO THE DIAGNOSTIC ROOM FOR SCANNING, WHICH WAS COMPLETED SUCCESSFULLY. THE CUSTOMER REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT; HOWEVER A DELAY GREATER THAN 60 MINUTES OCCURRED AND ADDITIONAL MEDICATION AND MONITORING WERE REQUIRED DURING THE MODIFICATION TO THE PLANNED IMAGING PORTION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397827 ↗
• MalfunctionDec 14, 2023Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  THE CUSTOMER REPORTED THAT DURING A CRANIOTOMY WITH INTRA-OPERATIVE IMAGING PLANNED, THE COLLISION DETECTION SYSTEM WAS ACTIVATED AND WOULD NOT LET THE USER MOVE THE MRI SCANNER. MULTIPLE ATTEMPTS TO TROUBLESHOOT WERE MADE BY THE USER BEFORE THE MRI SCANNER WAS FUNCTIONAL AGAIN. THE CUSTOMER REPORTED A DELAY TO THE PROCEDURE OF OVER ONE HOUR AND ADMINISTRATION OF ADDITIONAL ANESTHESIA TO COVER THE TIME DURING THE DELAY. THE CRANIOTOMY PROCEDURE WAS RESUMED AFTER IMAGING WAS OBTAINED, AND THE CUSTOMER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333025 ↗
• MalfunctionJun 20, 2023Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT DURING A CRANIOTOMY WITH INTRA-OPERATIVE IMAGING PLANNED, THE MRI MAGNET WOULD NOT MOVE DUE TO CONTINUOUS ERRORS FROM THE DEVICE'S COLLISION DETECTION SYSTEM. THE ERRORS PREVENTED INTENDED MRI MOVEMENT FROM THE DIAGNOSTIC ROOM TO THE IMAGING POSITION IN THE OPERATING ROOM, AND INTRA-OPERATIVE IMAGING WAS NOT POSSIBLE PRIOR TO CLOSURE OF THE SKULL. UPON COMPLETION OF THE SURGERY, THE SURGEON REMOVED THE PATIENT FROM THE SKULL PINS, DRESSED THE WOUND AND ORDERED POST-OPERATIVE MR IMAGING IN THE DIAGNOSTIC ROOM. IT WAS REPORTED THAT ADDITIONAL ANESTHESIA WAS ADMINISTERED AND APPROXIMATELY 45 MINUTES OF DELAY WAS INCURRED IN CONNECTION WITH THE SYSTEM ERRORS. THE PATIENT WAS REPORTED TO BE DOING WELL AFTER COMPLETION OF THE CASE AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED BASED ON POST-OPERATIVE IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212367. One submission often covers many models, so check the product and lot details in each record.

• Z-0164-2026 · Sep 30, 2025 · Open, Classified
  IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
• Z-0161-2026 · Sep 30, 2025 · Open, Classified
  IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
• Z-0162-2026 · Sep 30, 2025 · Open, Classified
  IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra