Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
fMRI Hardware System - AudioSystem Recalled by NordicNeuroLab AS Due to Report was of an interrupted MR scan after...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NordicNeuroLab AS directly.
Affected Products
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.
Quantity: 64 units
Why Was This Recalled?
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NordicNeuroLab AS
NordicNeuroLab AS has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report