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Class 2 Device Recall fMRI Hardware System AudioSystem, Version 1.0 |
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Date Initiated by Firm |
October 28, 2017 |
Create Date |
June 06, 2018 |
Recall Status1 |
Terminated 3 on March 31, 2021 |
Recall Number |
Z-2103-2018 |
Recall Event ID |
78848 |
510(K)Number |
K080515
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Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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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. |
Code Information |
HPS-2015-1.0-XXX HPS-2016-1.0-XXX |
Recalling Firm/ Manufacturer |
NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
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For Additional Information Contact |
866-665-3674
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Manufacturer Reason for Recall |
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
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FDA Determined Cause 2 |
Device Design |
Action |
The 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 Commerce |
64 units |
Distribution |
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 |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = NORDICNEUROLAB
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