NordicNeuroLab fMRI AudioSystem Recall: Acoustic Distortion Risk

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Recalling firmNordicNeuroLab ASMollendalsveien 65c, N/A · Bergen, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

NordicNeuroLab is recalling its fMRI AudioSystem Version 1.0 because it has caused reported acoustic distortion and heat from headphones during MRI scans. This could lead to interrupted scans or patient discomfort.

Why it’s dangerous

The AudioSystem can cause acoustic distortion and heat buildup in headphones during MRI scans, leading to interrupted scans or patient discomfort. This occurs when auditory signals from the stimulus presentation PC enter the scanner room.

Who’s affected

Patients and staff using NordicNeuroLab's fMRI AudioSystem Version 1.0 for MRI scans are affected. Those with the specific model numbers HPS-2015-1.0-XXX or HPS-2016-1.0-XXX are most at risk.

How to tell if you have this one

Check for the model numbers HPS-2015-1.0-XXX or HPS-2016-1.0-XXX on the AudioSystem. The product is used in fMRI MRI scanners for auditory signal transmission.

Brand
NordicNeuroLab
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Look for model numbers HPS-2015-1.0-XXX or HPS-2016-1.0-XXX on the AudioSystem.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to reported acoustic distortion and heat from headphones during MRI scans, which can cause interrupted scans or patient discomfort.

What model numbers are affected?

The affected model numbers are HPS-2015-1.0-XXX and HPS-2016-1.0-XXX.

Is there a fix for this issue?

The recall record does not mention a remedy or fix for this issue.

Take action

Contact NordicNeuroLab

We’ve drafted a message you can send NordicNeuroLab to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2103-2018 — NordicNeuroLab NordicNeuroLab

Hello,

I own a NordicNeuroLab that is covered by recall Z-2103-2018 from NordicNeuroLab.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2103-2018 (October 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2103-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

NordicNeuroLab AS recalls fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation

Lower-risk recall