iMRI 3T S OR-DR-OR 116053-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857534006035), received between Feb 2, 2022 and Feb 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Electromagnetic Interference” (1 report).

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

5 other recalls cover devices cleared under the same FDA submission (K133692); 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-0162-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2017, A SIEMENS SERVICE TECHNICIAN WAS WORKING ON A SOFTWARE UPGRADE IN THE EQUIPMENT ROOM POSITIONED ADJACENT TO THE MAGNET IN THE DIAGNOSTIC ROOM. AS THE TECHNICIAN WAS ATTEMPTING TO REMOVE AND REPLACE A COMPUTER SERVER FROM THE EQUIPMENT RACK, THE SERVER ATTRACTED TO THE MAGNET. THE TECHNICIAN'S LEFT HAND WAS CAUGHT BETWEEN THE SERVER AND THE MAGNET. THE TECHNICIAN WAS ABLE TO EXTRICATE HIS LEFT HAND FROM BETWEEN THE MAGNET AND THE EQUIPMENT, AND DAMAGE TO THE TECHNICIAN'S MIDDLE FINGER OCCURRED DURING THIS PROCESS. THE TECHNICIAN WAS TREATED IN THE EMERGENCY ROOM ONSITE. THE MAGNET WAS RAMPED DOWN TO RETRIEVE THE SERVER FROM THE SIDE OF THE MAGNET.

  Patient problems: Laceration(s)

  MAUDE report 13516141 ↗
• MalfunctionFeb 2, 2022Electromagnetic Interference; Electromagnetic Interference

  ON (B)(6) 2017, A HOSPITAL STAFF PICKED UP A BOX OF MAGNET SHIMS IN THE HOSPITAL'S EQUIPMENT ROOM WITHOUT KNOWING WHAT WAS INSIDE. THE STAFF BROUGHT THE BOX THROUGH THE MAGNETIC FIELD IN THE OPERATING ROOM AND THE BOX FELL OUT OF THE STAFF'S HAND. AS A RESULT, THE SHIMS FLEW INTO THE BORE OF THE MAGNET CAUSING A SUPERFICIAL DAMAGE TO THE BORE. THERE WAS NO PATIENT INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425258 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133692. One submission often covers many models, so check the product and lot details in each record.

• Z-0163-2026 · Sep 30, 2025 · Open, Classified
  IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
• 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-1645-2018 · Apr 4, 2018 · Terminated
  IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designa
• Z-1098-2016 · Feb 10, 2016 · Terminated
  Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).