Home / Recalls / NordicNeuroLab AS / Z-2050-2018

Z-2050-2018 Class II Terminated

Recalled by NordicNeuroLab AS — Bergen, N/A

Recall Details

Product Type
Devices
Report Date
June 13, 2018
Initiation Date
September 17, 2014
Termination Date
March 24, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 licenses

Product Description

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.

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.

Distribution Pattern

USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom

Code Information

version 2.1 and older

Other recalls by NordicNeuroLab AS

  • Z-1462-2022 Class II — nordicBrainEX, software versions 2.21 through 2.3.10 (June 16, 2022)
  • Z-3023-2018 Class II — fMRI Hardware System VisualSystem allows video signals from the stimulus prese (August 20, 2018)
  • Z-2103-2018 Class II — fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows audito (October 28, 2017)
  • Z-2061-2018 Class II — nordicICE v 2.3.14 nordicICE is an image processing software package to be us (July 3, 2015)
  • Z-2042-2018 Class II — nordicTumorEx 1.0 nordicTumorEx is an image processing software package to (December 15, 2014)
  • Z-2044-2018 Class II — nordicICE 2.3.14 Image processing software package used by trained profession (September 12, 2014)
  • Z-2045-2018 Class II — nordicBrainEX Product Usage: nordicBrainEx is an image processing software p (December 21, 2012)