Z-2042-2018Class II

nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals...

Name: Z-2042-2018 nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals...
Creator: NordicNeuroLab AS
Published: 2014-12-15
License: https://open.fda.gov/license/

NordicNeuroLab AS / initiated 2014-12-15 / Terminated / root cause: software

FDA source

NordicNeuroLab AS began a recall of nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical... on 2014-12-15. FDA classified it as Class II and gives the reason as "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". 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-2042-2018
Classification: Class II
Status: Terminated
Initiated: 2014-12-15
Posted: 2018-05-31
Terminated: 2021-03-24
Recalling firm: NordicNeuroLab AS
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 viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm notified their consignees of the software problem by email on December 14, 2014. For further questions please call (262) 337-2909.
Quantity in commerce: 16 licenses
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
Product codes and lots: Version 1.0.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2042-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2042-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-31

Product code LLZ

K123306Class IINordic TumorexNordicneurolab / cleared 2013-05-20

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)