BEUDAMED
    FDA Enforcement Class II Terminated

    nordicBrainEX, software versions 2.21 through 2.3.10

    Recall: Z-1462-2022 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1462-2022
    Event ID
    90480
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NordicNeuroLab AS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 3, 2022
    Initiation Date
    June 16, 2022
    Classification Date
    July 25, 2022
    Termination Date
    September 4, 2024
    Address
    Mollendalsveien 65c, Bergen, N/A, Norway

    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.

    Code Info

    UDI 07090042059015, software versions 2.21 through 2.3.10

    Distribution

    US Nationwide distribution.

    Quantity

    243 units