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 nordicneurolab

  • 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 nordicneurolab see related information
Date Initiated by Firm June 16, 2022
Create Date July 25, 2022
Recall Status1 Open3, Classified
Recall Number Z-1462-2022
Recall Event ID 90480
510(K)Number K133910  
Product Classification System, image processing, radiological - Product Code LLZ
Product nordicBrainEX, software versions 2.21 through 2.3.10
Code Information UDI 07090042059015, software versions 2.21 through 2.3.10
Recalling Firm/
Manufacturer		 NordicNeuroLab AS
Mollendalsveien 65c
Bergen Norway
For Additional Information Contact
+47 90 56 61 31
Manufacturer Reason
for Recall		 When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
FDA Determined
Cause 2		 Software design
Action The firm sent a notice regarding a Critical Bug in nordicBrainEx version 2.2.1 to 2.3.10 on 06/16/2022 by email. The notice explained the problem and advised users to use extra caution when viewing the exported results. A software revision will be released to correct the issue.
Quantity in Commerce 243 units
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = NORDICNEUROLAB
-
-