Z-2050-2018Class II

nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain...

Name: Z-2050-2018 nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain...
Creator: NordicNeuroLab AS
Published: 2014-09-17
License: https://open.fda.gov/license/

NordicNeuroLab AS / initiated 2014-09-17 / Terminated / root cause: software

FDA source

NordicNeuroLab AS began a recall of nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a... on 2014-09-17. 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-2050-2018
Classification: Class II
Status: Terminated
Initiated: 2014-09-17
Posted: 2018-06-01
Terminated: 2021-03-24
Recalling firm: NordicNeuroLab AS
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.
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 by email on 09/17/2014.
Quantity in commerce: 22 licenses
Distribution: USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
Product codes and lots: version 2.1 and older

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2050-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2050-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-01

Product code LLZ

K133910Class IINordicbrainexNordicneurolab / cleared 2014-04-04

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)