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U.S. Department of Health and Human Services

Class 2 Device Recall nordicICE v 2.3.14

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  Class 2 Device Recall nordicICE v 2.3.14 see related information
Date Initiated by Firm July 03, 2015
Create Date June 04, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-2061-2018
Recall Event ID 78467
510(K)Number K082441  
Product Classification System, image processing, radiological - Product Code LLZ
Product nordicICE v 2.3.14

nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
Code Information Version 2.3.14
Recalling Firm/
Manufacturer		 NordicNeuroLab AS
Mollendalsveien 65c
Bergen Norway
For Additional Information Contact
262-337-2909
Manufacturer Reason
for Recall		 The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not be adjusted according to the coregistration.
FDA Determined
Cause 2		 Software design
Action The firm notified their customers by email on July 3, 2015. Actions to be taken by the customer/User: We advise users to immediately stop using the BOLD module in nordiclCE and contact NordicNeuroLab for further instructions on how to upgrade the nordiclCE BOLD module, as described more fully below. For further questions, please call (262) 337-2909.
Quantity in Commerce 121 licenses
Distribution Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland.
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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