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

Recall date

October 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2103-2018

FDA classification

Class II

Brand / firm

NordicNeuroLab AS

Sold / 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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.