iMRX System iMRX System AR-DR-ORRecalls & reported problems
IMRIS Imaging, Inc. · iMRX System AR-DR-OR, MR30R, 105828-000 · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857534006165), 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 this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Output Problem1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.