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NordicNeuroLab AS Recalls
8 recalls on record · June 6, 2018 to August 3, 2022 · Medical Devices
Recalls by year
18
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 3, 2022Medical DevicesFDA
NordicNeuroLab AS recalls nordicBrainEX, software versions 2.21 through 2.3.10
Hazard: 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.
September 19, 2018Medical DevicesFDA
NordicNeuroLab AS recalls fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner
Hazard: Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).
June 13, 2018Medical DevicesFDA
NordicNeuroLab AS recalls fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentatio
Hazard: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
June 13, 2018Medical DevicesFDA
NordicNeuroLab AS recalls nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including bu
Hazard: 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.
June 13, 2018Medical DevicesFDA
NordicNeuroLab AS recalls nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the deri
Hazard: 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.
June 6, 2018Medical DevicesFDA
NordicNeuroLab AS recalls nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professiona
Hazard: 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 visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.
June 6, 2018Medical DevicesFDA
NordicNeuroLab AS recalls nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical t
Hazard: 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.
June 6, 2018Medical DevicesFDA
NordicNeuroLab AS recalls nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals includi
Hazard: 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.