FDA-Device2018-06-13Class II
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.
NordicNeuroLab AS
Hazard
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Sold states
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
Affected count
64 units
Manufactured in
Mollendalsveien 65c, N/A, Bergen, N/A, Norway
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2018Don't want to check this manually?
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