CLASS II Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

nordicBrainEX, software versions 2.21 through recalled

NordicNeuroLab AS is recalling nordicBrainEX, software versions 2.21 through 2.3.10, distributed nationwide in the US. The recall was initiated on 16 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 07090042059015, software versions 2.21 through 2.3.10

Quantity recalled243 units

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-1462-2022
FDA event ID: 90480
Recalling firm: NordicNeuroLab AS, Bergen
Classification: Class II
Status: Terminated
Recall initiated: 16 Jun 2022
FDA classified: 25 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

16 Jun 2022	Recall initiated by company
25 Jul 2022	Classified by FDA	+39 days
3 Aug 2022	Published in enforcement report	+9 days

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

Reason for recall

When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

nordicBrainEX, software versions 2.21 through 2.3.10

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is nordicBrainEX, software versions 2.21 through 2.3.10 recalled?

Yes. NordicNeuroLab AS recalled nordicBrainEX, software versions 2.21 through 2.3.10 on 16 Jun 2022. The recall is Class II and its status is Terminated. Recall number Z-1462-2022.

Why was it recalled?

Which lots are affected?

UDI 07090042059015, software versions 2.21 through 2.3.10

Where was it sold?

US Nationwide distribution.

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
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	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
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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