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U.S. Department of Health and Human Services

Class 2 Device Recall nordicICE 2.3.14

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  Class 2 Device Recall nordicICE 2.3.14 see related information
Date Initiated by Firm September 12, 2014
Create Date May 31, 2018
Recall Status1 Terminated 3 on October 06, 2020
Recall Number Z-2044-2018
Recall Event ID 78463
510(K)Number K082441  
Product Classification System, image processing, radiological - Product Code LLZ
Product nordicICE 2.3.14

Image processing software package used by trained professionals, including physicians and medical technicians.
Code Information Version 2.3.14
Recalling Firm/
Manufacturer		 NordicNeuroLab AS
Mollendalsveien 65c
Bergen Norway
Manufacturer Reason
for Recall		 An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
FDA Determined
Cause 2		 Software design
Action The firm notified their consignees by e-mail on 09/12/2014. Customers were informed of the reason for the recall, when the problem occurs, and what actions to take. Customers can perform a simple test by checking to see if there is a mismatch. Also, it is recommended that customers using BOLD and DTI, or other functionalities or workflows involving MPR switch to nordicBrainEx. Questions should be directed to NordicNeuroLab Customer Service at customerservice@nordicneurolab.com or 1-262-337-2909.
Quantity in Commerce 97 licenses
Distribution Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = NORDICIMAGINGLAB AS
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