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

fMRI Hardware System - AudioSystem recalled by NordicNeuroLab AS

NordicNeuroLab AS is recalling fMRI Hardware System - AudioSystem, distributed nationwide in the US. The recall was initiated on 28 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHPS-2015-1.0-XXX HPS-2016-1.0-XXX

Quantity recalled64 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-2103-2018
FDA event ID: 78848
Recalling firm: NordicNeuroLab AS, Bergen, N/A
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2017
FDA classified: 6 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

28 Oct 2017	Recall initiated by company
6 Jun 2018	Classified by FDA	+221 days
13 Jun 2018	Published in enforcement report	+7 days

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

Reason for recall

Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

Product as listed by the FDA

fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

Where it was distributed

Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria

Nationwide

Questions about this recall

Is fMRI Hardware System - AudioSystem recalled?

Yes. NordicNeuroLab AS recalled fMRI Hardware System - AudioSystem on 28 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-2103-2018.

Why was it recalled?

Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

Which lots are affected?

HPS-2015-1.0-XXX HPS-2016-1.0-XXX

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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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	nordicBrainEx 0 provides analysis recalled by NordicNeuroLab AS	NordicNeuroLab AS	Lead & Heavy Metals	N/A
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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