ORT400 Table 119900-000Recalls & reported problems
IMRIS Imaging, Inc. · ORT400 Table · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857534006691), received between Oct 15, 2021 and Nov 12, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2021Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT DURING A MAGNETIC RESONANCE-GUIDED LITT PROCEDURE, THE AREA INTENDED FOR ABLATION APPEARED TO BE OFF TARGET, PRIOR TO ABLATION. THE CASE WAS COMPLETED AND NO PATIENT OR PROCEDURAL IMPACT OR CONSEQUENCE WAS REPORTED. THE PLANNED THERAPY WAS DELIVERED AFTER THE NEUROSURGEON COMPENSATED FOR THE OBSERVED SHIFT IN IMAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12801533 ↗MalfunctionOct 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A MAGNETIC RESONANCE-GUIDED LITT PROCEDURE, THE AREA TARGETED FOR ABLATION APPEARED, PRIOR TO ABLATION, TO BE 4.5 MM TO 8 MM OFF TARGET. THE CASE WAS COMPLETED AFTER NOTING THE POSSIBLE IMAGE DISTORTION ISSUE AND NO PATIENT IMPACT OR CONSEQUENCE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12637520 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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