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U.S. Department of Health and Human Services

Class 2 Device Recall fMRI Hardware System AudioSystem, Version 1.0

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 Class 2 Device Recall fMRI Hardware System AudioSystem, Version 1.0see related information
Date Initiated by FirmOctober 28, 2017
Create DateJune 06, 2018
Recall Status1 Terminated 3 on March 31, 2021
Recall NumberZ-2103-2018
Recall Event ID 78848
510(K)NumberK080515 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductfMRI 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.
Code Information HPS-2015-1.0-XXX HPS-2016-1.0-XXX
FEI Number 3006738448
Recalling Firm/
Manufacturer		 NordicNeuroLab AS
Mollendalsveien 65c
Bergen Norway
For Additional Information Contact
866-665-3674
Manufacturer Reason
for Recall		Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
FDA Determined
Cause 2		Device Design
ActionThe firm notified the consignees by email on September 28, 2017. The units were to be returned. For further questions, please call 1 (855) 665-3674 option 1.
Quantity in Commerce64 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LNH
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