| Class 2 Device Recall nordicBrainEx 2.0 | |
Date Initiated by Firm | September 17, 2014 |
Create Date | June 01, 2018 |
Recall Status1 |
Terminated 3 on March 24, 2021 |
Recall Number | Z-2050-2018 |
Recall Event ID |
78466 |
510(K)Number | K133910 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context. |
Code Information |
version 2.1 and older |
Recalling Firm/ Manufacturer |
NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
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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 email on 09/17/2014. |
Quantity in Commerce | 22 licenses |
Distribution | USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom |
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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