iMRX SystemRecalls & reported problems across all models

We found 2 models of iMRX System by IMRIS Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 24, 2024 and Aug 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

iMRX System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 30, 2025Open, 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-0161-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported iMRX System problems

iMRX System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• iMRX System iMRX System AR-DR-OR

  System, Nuclear Magnetic Resonance Imaging
  1 recall1 report
• iMRX System iMRX System AR-DR MR30RS

  System, X-Ray, Angiographic
  1 recall0 reports

Recent iMRX System adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2024Output Problem; Unexpected Shutdown; Output Problem; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT DURING AN MR-GUIDED ABLATION TREATMENT FOR TEMPORAL LOBE TUMOR, THE MRI SCANNER WOULD NOT FUNCTION. THE CUSTOMER REPORTED THE TARGET WAS ESTABLISHED, LASER PROBE INSERTED IN THE CRANIAL BOLT FIXATION READY FOR THERMO-THERAPY WHEN SCANS KEPT ABORTING. THE SCANNER WOULD RUN 40 SECS THEN ABORT. ALL ATTEMPTS WERE EXHAUSTED BY THE NEUROSURGEON WHO AFTER FOUR HOURS DECIDED TO RESCHEDULE THE TREATMENT FOR THE FOLLOWING WEEK. INTRA-OP AND POST-OP SCANS WERE INCLUSIVE REGARDING THERAPY TO TARGETED AREA. THE CUSOTMER REPORTED THERE WAS NO ADVERSE OUTCOME TO THE PATIENT WHO WAS DISCHARGED THE FOLLOWING DAY WITH AN APPOINTMENT TO RETURN THE NEXT WEEK FOR ADDITIONAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20058884 ↗

Other IMRIS Imaging, Inc. products

• ORT300 Table2 models · 27 reports · 3 recalls
• HFD1003 models · 7 reports · 2 recalls
• iMRI 3T S4 models · 7 reports · 1 recall
• Neuro III-SV iMRI System2 models · 0 reports · 1 recall