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NordicNeuroLab AS recalls fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentatio
Recalled June 13, 2018 · FDA recall Z-2103-2018 · NordicNeuroLab AS
Hazard
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. · FDA Class II
Units
64 units
Sold at
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
Description
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Product
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.
Manufacturer(s)
NordicNeuroLab AS
Made in
Norway
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →