RegWardenFDA facility compliance records
Company

NORDICNEUROLAB AS

8 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2014: 3 recalls; 2015: 1 recalls; 2017: 1 recalls; 2018: 1 recalls; 2022: 1 recalls1’12’133’141’15’161’171’18’19’20’211’22’23’24’25’26
  • Recalls (8)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2022-06-16
    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.
  • Class IITerminated2018-08-20
    Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).
  • Class IITerminated2017-10-28
    Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
  • Class IITerminated2015-07-03
    The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not be adjusted according to the coregistration.
  • Class IITerminated2014-12-15
    An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
  • Class IITerminated2014-09-17
    An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
  • Class IITerminated2014-09-12
    An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
  • Class IITerminated2012-12-21
    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 visu…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NORDICNEUROLAB AS — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9098320-nordicneurolab-as/

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