Bergen, N/A, Norway
NordicNeuroLab AS recalls
8 recalls recorded since 2018, most recently on 16 June 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)0
Terminated or completed8
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 June 2022
- Terminated
- 4 September 2024
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1462-2022
- nordicBrainEX, software versions 2.21 through 2.3.10
Terminated Class II Medical devices
- Recall started
- 20 August 2018
- Terminated
- 16 September 2020
- Reason
- Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3023-2018
- 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 P
Terminated Class II Medical devices
- Recall started
- 28 October 2017
- Terminated
- 31 March 2021
- Reason
- Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2103-2018
- 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 th
Terminated Class II Medical devices
- Recall started
- 3 July 2015
- Terminated
- 16 September 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2061-2018
- 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
Terminated Class II Medical devices
- Recall started
- 15 December 2014
- Terminated
- 24 March 2021
- Reason
- 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.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2042-2018
- 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-s
Terminated Class II Medical devices
- Recall started
- 17 September 2014
- Terminated
- 24 March 2021
- Reason
- 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.
- Distribution
- USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2050-2018
- 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.
Terminated Class II Medical devices
- Recall started
- 12 September 2014
- Terminated
- 6 October 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2044-2018
- nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Terminated Class II Medical devices
- Recall started
- 21 December 2012
- Terminated
- 16 September 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2045-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.