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Class 2 Device Recall nordicBrainEx 2.0 |
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| 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
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| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| 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
|
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 and Original Applicant = NORDICNEUROLAB
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