CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report

nordicBrainEx 0 provides analysis recalled by NordicNeuroLab AS

NordicNeuroLab AS is recalling nordicBrainEx 0 provides analysis and visualization capabilities of dynamic MRI data of. The recall was initiated on 17 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesversion 2.1 and older

Quantity recalled22 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-2050-2018
FDA event ID: 78466
Recalling firm: NordicNeuroLab AS, Bergen, N/A
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2014
FDA classified: 1 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

17 Sep 2014	Recall initiated by company
1 Jun 2018	Classified by FDA	+1353 days
13 Jun 2018	Published in enforcement report	+12 days

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

Reason for recall

An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom

Questions about this recall

Is nordicBrainEx 0 provides analysis and visualization capabilities of dynamic MRI data of recalled?

Yes. NordicNeuroLab AS recalled nordicBrainEx 0 provides analysis and visualization capabilities of dynamic MRI data of on 17 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-2050-2018.

Why was it recalled?

Which lots are affected?

version 2.1 and older

Where was it sold?

USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom

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 21 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 from recalled	NordicNeuroLab AS	Other	N/A
13 Jun 2018Device	CLASS II	nordicICE v 3.14 nordicICE is an image processing recalled	NordicNeuroLab AS	Packaging Defects	Nationwide
13 Jun 2018Device	CLASS II	fMRI Hardware System - AudioSystem recalled by NordicNeuroLab AS	NordicNeuroLab AS	Other	Nationwide
6 Jun 2018Device	CLASS II	nordicICE 3.14 Image processing recalled by NordicNeuroLab AS	NordicNeuroLab AS	Lead & Heavy Metals	N/A

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