The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2050-2018·Announced 2018-06-13

NordicNeuroLab Recalls nordicBrainEx 2.0 Software Due to Image Orientation Errors

NordicNeuroLab AS is recalling nordicBrainEx 2.0 software versions 2.1 and older because a DICOM header error may cause incorrect image orientation labeling.

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. The hazard involves incorrect image orientation labeling, which is a significant software defect but does not involve direct physical injury or death, fitting the Moderate category for software defects without reported harm.

Plain-English summary

NordicNeuroLab AS is recalling 22 licenses of nordicBrainEx 2.0 software, version 2.1 and older. This software provides analysis and visualization capabilities for dynamic MRI data of the brain. The recall affects units distributed in the USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, and the United Kingdom.

The recall was initiated because an error was discovered in the interpretation of certain DICOM header tags. This error may lead to incorrect orientation labeling, resulting in an indirect left-right, up-down, or anterior-posterior flipping of images.

Users of the affected software should stop using the product and contact NordicNeuroLab AS for further instructions on how to resolve the issue.

The recalled product

Product
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Manufacturer
NordicNeuroLab AS
Category
Medical Device — Software
Hazard
Affected units
22

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 2.1 and older

Distribution

Distribution scope not specified by the agency.

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