OmniTom Elite PCD 0-NL5100-001Recalls & reported problems
Neurologica Corp. · Class 2
Data updated Oct 18, 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 10815411020847), received between Mar 3, 2025 and Feb 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Calibration Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Calibration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unintended Radiation Exposure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Appropriate Device Problem Term/Code Not Available
THE SCANNER STOPPED MID-SCAN. AFTER RESTARTING THE SCAN, IT FINISHED SUCCESSFULLY, BUT UNABLE TO VIEW THE IMAGES ON THE TABLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474946 ↗MalfunctionMar 3, 2025Calibration Problem; Calibration Problem
THE PATIENT HAD TO BE RESCANNED DUE TO ARTIFACT IN THE IMAGES.
Patient problems: Unintended Radiation Exposure
MAUDE report 21503646 ↗
Other System, X-Ray, Tomography, Computed devices
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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