The Recall Desk

Manufacturer

NordicNeuroLab AS

8 recalls in our database name NordicNeuroLab AS as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2022-08-03

Of the 8 recalls from NordicNeuroLab AS we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • HighFDA (Devices)·Z-1462-2022·2022-08-03

    Medical imaging software may flip left-right brain image orientation

    NordicBrainEX software versions 2.21-2.3.10 may export brain imaging with reversed left-right orientation in certain analysis scenarios, potentially causing diagnostic misinterpretation.

    Product
    nordicBrainEX, software versions 2.21 through 2.3.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3023-2018·2018-09-19

    NordicNeuroLab Recalls fMRI LCD Monitor Power Supplies Due to Magnet Bore Risk

    NordicNeuroLab AS is recalling 163 LCD monitor power supplies for fMRI systems because they were reported to be dragged into the magnet bore.

    Product
    fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2103-2018·2018-06-13

    NordicNeuroLab fMRI AudioSystem Recalled for Acoustic Distortion and Heat

    NordicNeuroLab AS is recalling 64 fMRI AudioSystem units after a patient reported acoustic distortion and heat from headphones during a scan.

    Product
    fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2018·2018-06-13

    NordicNeuroLab Recalls nordicICE Software Due to Coregistration Visualization Error

    NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.

    Product
    nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2018·2018-06-13

    NordicNeuroLab Recalls nordicBrainEx 2.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling nordicBrainEx 2.0 software versions 2.1 and older because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2042-2018·2018-06-06

    NordicNeuroLab Recalls nordicTumorEx 1.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling 16 licenses of nordicTumorEx 1.0 software because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2018·2018-06-06

    NordicNeuroLab Recalls nordicBrainEX Software Due to Fiber Tract Alignment Error

    NordicNeuroLab AS is recalling 36 licenses of nordicBrainEX version 1.1.2 because a software error can cause fiber tracts to be misaligned when switching between image series with identical resolutions.

    Product
    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2018·2018-06-06

    NordicNeuroLab Recalls nordicICE 2.3.14 Image Processing Software

    NordicNeuroLab AS is recalling 97 licenses of nordicICE 2.3.14 image processing software due to a defect that may cause incorrect orientation labeling and image flipping.

    Product
    nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
    Category
    Medical Device
    Distribution
    0 states