Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2045-2018·Announced 2018-06-06

NordicNeuroLab Recalls nordicBrainEX Software Due to Fiber Tract Alignment Error

NordicNeuroLab AS is recalling 36 licenses of nordicBrainEX version 1.1.2 because a software error can cause fiber tracts to be misaligned when switching between image series with identical resolutions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software error that results in misaligned data but does not report any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary recalls without reported harm.

Plain-English summary

NordicNeuroLab AS is recalling 36 licenses of nordicBrainEX version 1.1.2, an image processing software package used by trained professionals to view, process, and analyze medical images. The software is distributed worldwide, including in the United States, Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, and Japan.

The recall is due to an error in the relative geometry between fiber tracts in a fiber group and images. The error occurs when a group of fibers is selected using the Volume of Interest (VOI) functionality while one image series is visualized, and then a second image series with the same geometrical resolution is visualized. In this scenario, the coregistration matrix is not applied to the fiber group, causing the fibers to be positioned incorrectly in the 3D viewer, MPR, or when exported as a new image series.

Users of the affected software should contact NordicNeuroLab AS for further instructions regarding the recall and potential corrective actions.

The recalled product

Product: nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform…
Manufacturer: NordicNeuroLab AS
Category: Medical Device — Software
Hazard: software-error
data-misalignment
Affected units: 36

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

version 1.1.2

Distribution

Distributed nationwide across the United States.

Same manufacturer · NordicNeuroLab AS

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