NordicNeuroLab AS Mollendalsveien 65c Bergen Norway nordicBrainEX, software versions 2.21 through 2.3.10 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
nordicBrainEX, software versions 2.21 through 2.3.10
Brand
NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
Lot Codes / Batch Numbers
UDI 07090042059015, software versions 2.21 through 2.3.10
Products Sold
UDI 07090042059015, software versions 2.21 through 2.3.10
NordicNeuroLab AS Mollendalsveien 65c Bergen Norway is recalling nordicBrainEX, software versions 2.21 through 2.3.10 due to When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026