medical Class II Updated 2018-06-13

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

Distribution: Nationwide (United States)
Lot/Code Info: HPS-2015-1.0-XXX HPS-2016-1.0-XXX
View official government recall

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