CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG 0-NL3000-005Recalls & reported problems

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 10815411020342), received between May 13, 2026 and May 19, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Image Display Error/Artifact1
Insufficient Device Problem Information1

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.

MalfunctionMay 19, 2026Image Display Error/Artifact
THE ARTIFACT ISSUE WITH THE MACHINE REQUIRES RE-SCANNING THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25225283 ↗
MalfunctionMay 13, 2026Insufficient Device Problem Information
THE SYSTEM FREEZES UP DURING A SCAN CAUSING THE DELAY IN THE TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166321 ↗

Device details

UDI-DI	`10815411020342`
Brand	CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG
Model	0-NL3000-005
Company	Neurologica Corp.
Product code	JAK · System, X-Ray, Tomography, Computed
Class	Class 2
FDA submission	K172539
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 4, 2019

Device type (GMDN): Limited-view-field CT system

An assembly of diagnostic x-ray computed tomography (CT) devices having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

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All System, X-Ray, Tomography, Computed devices →

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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