Z-1462-2022Class II

nordicBrainEX, software versions 2.21 through 2.3.10

Name: Z-1462-2022 nordicBrainEX, software versions 2.21 through 2.3.10
Creator: NordicNeuroLab AS
Published: 2022-06-16
License: https://open.fda.gov/license/

NordicNeuroLab AS / initiated 2022-06-16 / Terminated / root cause: software

FDA source

NordicNeuroLab AS began a recall of nordicBrainEX, software versions 2.21 through 2.3.10 on 2022-06-16. FDA classified it as Class II and gives the reason as "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". 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-1462-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-16
Posted: 2022-07-25
Terminated: 2024-09-04
Recalling firm: NordicNeuroLab AS
Product: nordicBrainEX, software versions 2.21 through 2.3.10
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm sent a notice regarding a Critical Bug in nordicBrainEx version 2.2.1 to 2.3.10 on 06/16/2022 by email. The notice explained the problem and advised users to use extra caution when viewing the exported results. A software revision will be released to correct the issue.
Quantity in commerce: 243 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI 07090042059015, software versions 2.21 through 2.3.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1462-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1462-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-03	2022-07-25

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)