Z-2045-2018Class II

nordicBrainEX

Name: Z-2045-2018 nordicBrainEX
Creator: NordicNeuroLab AS
Published: 2012-12-21
License: https://open.fda.gov/license/

NordicNeuroLab AS / initiated 2012-12-21 / Terminated / root cause: software

FDA source

NordicNeuroLab AS began a recall of nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians... on 2012-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2045-2018
Classification: Class II
Status: Terminated
Initiated: 2012-12-21
Posted: 2018-06-01
Terminated: 2020-09-16
Recalling firm: NordicNeuroLab AS
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 image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm distributed the recall notification letter by email. The letter identified the affected product, problem and the actions to be taken. For questions contact NordicNeurolab Customer Service or if you would like to arrange a return [email protected].
Quantity in commerce: 36 licenses
Distribution: Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan
Product codes and lots: version 1.1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2045-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2045-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-31

Product code LLZ

K092102Class IINordicbrainex Software, Version 1.0Nordicimaginglab AS / cleared 2009-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)