Z-2061-2018Class II

nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals...

Name: Z-2061-2018 nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals...
Creator: NordicNeuroLab AS
Published: 2015-07-03
License: https://open.fda.gov/license/

NordicNeuroLab AS / initiated 2015-07-03 / Terminated / root cause: software

FDA source

NordicNeuroLab AS began a recall of 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... on 2015-07-03. FDA classified it as Class II and gives the reason as "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...". 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-2061-2018
Classification: Class II
Status: Terminated
Initiated: 2015-07-03
Posted: 2018-06-04
Terminated: 2020-09-16
Recalling firm: NordicNeuroLab AS
Product: 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 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. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm notified their customers by email on July 3, 2015. Actions to be taken by the customer/User: We advise users to immediately stop using the BOLD module in nordiclCE and contact NordicNeuroLab for further instructions on how to upgrade the nordiclCE BOLD module, as described more fully below. For further questions, please call (262) 337-2909.
Quantity in commerce: 121 licenses
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.
Product codes and lots: Version 2.3.14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2061-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2061-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-04

Product code LLZ

K082441Class IINordicice SoftwareNordicimaginglab AS / cleared 2008-11-21

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)