CLASS II Device recall · Reported 6 Jun 2018 · FDA Enforcement Report

nordicBrainEX Product Usage: nordicBrainEx is an image processing recalled

NordicNeuroLab AS is recalling nordicBrainEX Product Usage: nordicBrainEx is an image processing, distributed nationwide in the US. The recall was initiated on 21 Dec 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesversion 1.1.2

Quantity recalled36 licenses

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2045-2018
FDA event ID: 80162
Recalling firm: NordicNeuroLab AS, Bergen, N/A
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2012
FDA classified: 31 May 2018
Reported: 6 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

21 Dec 2012	Recall initiated by company
31 May 2018	Classified by FDA	+1987 days
6 Jun 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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 image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

Where it was distributed

Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

version 1.1.2

Where was it sold?

Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from NordicNeuroLab AS

All 8

Reported	Class	Recall	Company	Reason	Where
3 Aug 2022Device	CLASS II	nordicBrainEX, software versions 2.21 through recalled	NordicNeuroLab AS	Device Malfunction	Nationwide
19 Sep 2018Device	CLASS II	fMRI Hardware System VisualSystem allows video signals recalled	NordicNeuroLab AS	Other	N/A
13 Jun 2018Device	CLASS II	nordicICE v 2.3.14 nordicICE is an image processing recalled	NordicNeuroLab AS	Packaging Defects	Nationwide
13 Jun 2018Device	CLASS II	nordicBrainEx 2.0 provides analysis recalled by NordicNeuroLab AS	NordicNeuroLab AS	Other	N/A
13 Jun 2018Device	CLASS II	fMRI Hardware System - AudioSystem recalled by NordicNeuroLab AS	NordicNeuroLab AS	Other	Nationwide

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