Home / Recalls / NordicNeuroLab AS / Z-2103-2018

Z-2103-2018 Class II Terminated

Recalled by NordicNeuroLab AS — Bergen, N/A

Recall Details

Product Type
Devices
Report Date
June 13, 2018
Initiation Date
October 28, 2017
Termination Date
March 31, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
64 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

HPS-2015-1.0-XXX HPS-2016-1.0-XXX

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