NordicNeuroLab AS recalls fMRI Hardware System - AudioSystem, Version 1.0 The Audio
Recalled 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.
Hazard / Issue
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Issued by
FDA
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