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NordicNeuroLab AS

Complete recall history across all FDA and CPSC categories — 8 total recalls

NordicNeuroLab AS appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by NordicNeuroLab AS

Date Product Reason Class
Jun 16, 2022 nordicBrainEX, software versions 2.21 through 2.3.10 When exporting merged results from the BOLD, DSC, and DCE modules of nordicBr... Class II
Aug 20, 2018 fMRI Hardware System VisualSystem allows video signals from the stimulus pr... Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being... Class II
Oct 28, 2017 fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows aud... Report was of an interrupted MR scan after patient complained about acoustic ... Class II
Jul 3, 2015 nordicICE v 2.3.14 nordicICE is an image processing software package to be... The bug causes BOLD activation maps to be visualized as overlays without tak... Class II
Dec 15, 2014 nordicTumorEx 1.0 nordicTumorEx is an image processing software package ... An error was discovered in the interpretation of certain DICOM header tags th... Class II
Sep 17, 2014 nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic... An error was discovered in the interpretation of certain DICOM header tags th... Class II
Sep 12, 2014 nordicICE 2.3.14 Image processing software package used by trained profess... An error was discovered in the interpretation of certain DICOM header tags th... Class II
Dec 21, 2012 nordicBrainEX Product Usage: nordicBrainEx is an image processing softwar... There is an error related to the relative geometry between fiber tracts in a ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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