BEUDAMED
    FDA Recall Terminated

    nordicBrainEX, software versions 2.21 through 2.3.10

    Recall: Z-1462-2022 · Initiated June 16, 2022

    Recall

    Recall Number
    Z-1462-2022
    Event Number
    90480
    Firm
    NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
    FEI Number
    3006738448
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 16, 2022
    Terminated
    September 4, 2024

    Description

    nordicBrainEX, software versions 2.21 through 2.3.10

    Reason

    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.

    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.

    Distribution

    US Nationwide distribution.

    Quantity

    243 units