iMRI 3T SRecalls & reported problems across all models

We found 4 models of iMRI 3T S by IMRIS Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2022 and Nov 11, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (3 reports).

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

iMRI 3T S 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, 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 · names 4 of these models · Recall details · FDA record ↗

Most reported iMRI 3T S problems

iMRI 3T S models

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

• iMRI 3T S OR-DR, 116118-000

  System, Nuclear Magnetic Resonance Imaging
  1 recall5 reports
• iMRI 3T S OR-DR-OR 116053-000

  System, Nuclear Magnetic Resonance Imaging
  1 recall2 reports
• iMRI 3T S OR-DR-OR 116117-000

  System, Nuclear Magnetic Resonance Imaging
  1 recall0 reports
• iMRI 3T S OR-DR 116119-000

  System, Nuclear Magnetic Resonance Imaging
  1 recall0 reports

Recent iMRI 3T S adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Device Handling Problem; Device Handling Problem

  THE PATIENT WAS TRANSPORTED INTO THE MRI DIAGNOSTIC ROOM (ZONE 4) BY A HOSPITAL EMPLOYEE VIA WHEELCHAIR. THE PATIENT WAS IN A SEATED POSITION WHEN THE SEAT AND BACK SUPPORT MATERIAL BEGAN TO FOLD/COLLAPSE DUE TO THE FERROUS PROPERTIES OF THE METAL SUPPORT FRAME AS THE WHEELCHAIR WAS PULLED (ATTRACTED) TO THE MAGNET'S BORE. THE MAGNET WAS INTENTIONALLY QUENCHED BY ONE OF THE MRI TECHNOLOGIST OUT OF CONCERN FOR PATIENT SAFETY. IT WAS REPORTED THE LEFT SIDE OF THE PATIENT'S BODY MADE CONTACT WITH THE BORE. PER INFORMATION VERBALLY PROVIDED TO THE IMRIS CUSTOMER SERVICE ENGINEER, X-RAYS OF THE PATIENT WERE OBTAINED AND REPORTED AS NEGATIVE (NO SPECIFIC ANATOMIC AREA OF INTEREST WAS PROVIDED), MINOR BRUSING OF PATIENT WAS REPORTED; HOWEVER, NO SERIOUS INJURY WAS REPORTED TO THE MRI TECHNOLOGIST OR OTHERS PRESENT WHEN THE EVENT OCCURRED.

  Patient problems: Bruise/Contusion

  MAUDE report 23528797 ↗
• MalfunctionMay 21, 2024Mechanical Jam; Mechanical Jam

  DURING PMCF SURVEY COLLECTION THE CUSTOMER IDENTIFIED AN EARLIER EVENT WHERE THE MRI SCANNER WAS NOT ABLE TO BE MOVED FROM THE DIAGNOSTIC ROOM TO THE OPERATING ROOM TO OBTAIN INTRA-OPERATIVE DIAGNOSTIC IMAGES. THE MAGNET MOVER PRODUCED AN ERROR MESSAGE AND DISALLOWED LINEAR MOVEMENT INTO THE OPERATING ROOM. THE PATIENT WAS TRANSFERRED TO ANOTHER STATIONARY MR SCANNER AT THE RADIOLOGY DEPARTMENT WHILE STILL UNDER ANESTHESIA. THE CUSTOMER REPORTED THE PROCEDURE COULD BE COMPLETED ALTHOUGH WITH SIGNIFICANT DELAY GREATER THAN 60 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367856 ↗
• 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 3, 2022Unintended Collision; Device Handling Problem; Unintended Collision; Device Handling Problem

  WHILE MOVING THE MAGNET FROM THE OPERATING ROOM TO THE DIAGNOSTIC ROOM ON (B)(6) 2020, A STAFF MEMBER BROUGHT IN AN MR-UNSAFE LINEN CART AND IT WAS DRAWN INTO THE MAGNET. THE MAGNET WAS PHYSICALLY DAMAGED BY THE LINEN CART, BREAKING THE FRONT FUNNEL COVER, THE COLLISION DETECTION RING, AND SOME ELECTRICAL CONNECTIONS INSIDE THE BODY COIL. THERE WAS NO PATIENT INVOLVEMENT AND THE USER DID NOT SUSTAIN ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446585 ↗
• 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 ↗
• MalfunctionFeb 2, 2022Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  ON (B)(6) 2019, AN IMRIS PROGRAM MANAGER WAS INSIDE THE NEWLY CONSTRUCTED AND INSTALLED OR SUITE WITH TWO PHOTOGRAPHERS. A FERROUS OBJECT WAS DRAWN FROM THE HAND OF ONE OF THE PHOTOGRAPHERS INTO THE BORE OF THE MAGNET. THERE WAS NO PATIENT INVOVLEMENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425087 ↗
• MalfunctionFeb 2, 2022Unintended Collision; Device Handling Problem; Unintended Collision; Device Handling Problem

  ON (B)(6) 2019, IT WAS REPORTED THAT A CLEANING PERSONNEL WAS IN THE MAGNETIC RESONANCE SUITE WHILE THE MAGNET WAS DEPLOYED. AN MR-UNSAFE TROLLEY WAS DRAWN INTO THE MAGNET, DAMAGING THE FUNNEL COVER AND COLLISION DETECTION RING. THERE WAS NO PATIENT INVOLVEMENT AND THE USER DID NOT SUSTAIN ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424965 ↗

Other IMRIS Imaging, Inc. products

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