The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2044-2018·Announced 2018-06-06

NordicNeuroLab Recalls nordicICE 2.3.14 Image Processing Software

NordicNeuroLab AS is recalling 97 licenses of nordicICE 2.3.14 image processing software due to a defect that may cause incorrect orientation labeling and image flipping.

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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect involves image orientation errors, which is a significant functional issue but does not explicitly report injuries or deaths, fitting the Moderate criteria for a software defect without reported harm.

Plain-English summary

NordicNeuroLab AS is recalling 97 licenses of the nordicICE 2.3.14 image processing software package. This software is used by trained professionals, including physicians and medical technicians, to process medical images.

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.

The affected software was distributed worldwide, including in the USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia. Users of the software should contact NordicNeuroLab AS for further instructions on how to address the defect.

The recalled product

Product
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Manufacturer
NordicNeuroLab AS
Category
Medical Device — Software
Hazard
Affected units
97

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

Distribution scope not specified by the agency.

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