| Class 2 Device Recall nordicICE v 2.3.14 | |
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
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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
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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 |
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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 = LLZ
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