The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2061-2018·Announced 2018-06-13

NordicNeuroLab Recalls nordicICE Software Due to Coregistration Visualization Error

NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.

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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.

Plain-English summary

NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14, an image processing software package used by trained professionals such as physicians and medical technicians. The software is designed to run on standard PC workstations to perform image viewing, processing, and analysis of medical images, including functional and dynamic imaging datasets acquired with MRI or other modalities.

The recall is due to a software bug that causes Blood Oxygen Level Dependent (BOLD) activation maps to be visualized as overlays without taking coregistration into account. Consequently, any output created from these activation maps as overlays will not be adjusted according to the coregistration.

The affected software was distributed worldwide, including nationwide in the United States and in Australia, Belgium, Brazil, China, the Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, the Netherlands, Norway, and Poland. Users of the affected software version should contact NordicNeuroLab AS for further instructions regarding the recall.

The recalled product

Product
nordicICE v 2.3.14 nordicICE 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 image viewing…
Manufacturer
NordicNeuroLab AS
Category
Medical Device — Software
Hazard
Affected units
121

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 2.3.14

Distribution

Distributed nationwide across the United States.

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