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

nordicICE 3.14 Image processing recalled by NordicNeuroLab AS

NordicNeuroLab AS is recalling nordicICE 3.14 Image processing. The recall was initiated on 12 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 2.3.14

Quantity recalled97 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-2044-2018
FDA event ID: 78463
Recalling firm: NordicNeuroLab AS, Bergen, N/A
Classification: Class II
Status: Terminated
Recall initiated: 12 Sep 2014
FDA classified: 31 May 2018
Reported: 6 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Medical Software

Timeline

12 Sep 2014	Recall initiated by company
31 May 2018	Classified by FDA	+1357 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

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

nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.

Where it was distributed

Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.

Questions about this recall

Is nordicICE 3.14 Image processing recalled?

Yes. NordicNeuroLab AS recalled nordicICE 3.14 Image processing on 12 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-2044-2018.

Why was it recalled?

Which lots are affected?

Version 2.3.14

Where was it sold?

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

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Reported	Class	Recall	Company	Reason	Where
3 Aug 2022Device	CLASS II	nordicBrainEX, software versions 2.21 through recalled	NordicNeuroLab AS	Device Malfunction	Nationwide
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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	nordicBrainEx 0 provides analysis recalled by NordicNeuroLab AS	NordicNeuroLab AS	Lead & Heavy Metals	N/A
13 Jun 2018Device	CLASS II	fMRI Hardware System - AudioSystem recalled by NordicNeuroLab AS	NordicNeuroLab AS	Other	Nationwide

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