iMRI 3T S OR-DR, 116118-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857534006059), received between Feb 2, 2022 and Nov 11, 2025 — classified as 5 malfunctions.

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

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 5 most recent of 5 reports, 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 ↗
• 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, 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 ↗

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-0164-2026 · Sep 30, 2025 · Open, Classified
  IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
• Z-0163-2026 · Sep 30, 2025 · Open, Classified
  IMRIS Operating Suite, IMRIS iMRI 3T V, 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).