Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall nordicBrainEX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall nordicBrainEX see related information
Date Initiated by Firm December 21, 2012
Create Date June 01, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-2045-2018
Recall Event ID 80162
510(K)Number K092102  
Product Classification System, image processing, radiological - Product Code LLZ
Product nordicBrainEX

Product Usage:
nordicBrainEx 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.
Code Information version 1.1.2
Recalling Firm/
Manufacturer		 NordicNeuroLab AS
Mollendalsveien 65c
Bergen Norway
Manufacturer Reason
for Recall		 There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.
FDA Determined
Cause 2		 Software design
Action The firm distributed the recall notification letter by email. The letter identified the affected product, problem and the actions to be taken. For questions contact NordicNeurolab Customer Service or if you would like to arrange a return customerservice@nordicneurolab.com.
Quantity in Commerce 36 licenses
Distribution Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan
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
-
-