Neuro III-SV iMRI SystemRecalls & reported problems across all models

We found 2 models of Neuro III-SV iMRI System by IMRIS Imaging, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

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

Neuro III-SV iMRI 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 ↗

Neuro III-SV iMRI System models

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

• Neuro III-SV iMRI System

  System, Nuclear Magnetic Resonance Imaging
  1 recall0 reports
• Neuro III-SV iMRI System

  System, Nuclear Magnetic Resonance Imaging
  1 recall0 reports

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
• iMRX System2 models · 1 reports · 1 recall