Home / Recalls / NordicNeuroLab AS / Z-1462-2022

Z-1462-2022 Class II Terminated

Recalled by NordicNeuroLab AS — Bergen

Recall Details

Product Type
Devices
Report Date
August 3, 2022
Initiation Date
June 16, 2022
Termination Date
September 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
243 units

Product Description

nordicBrainEX, software versions 2.21 through 2.3.10

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.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI 07090042059015, software versions 2.21 through 2.3.10

Other recalls by NordicNeuroLab AS

  • 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-2050-2018 Class II — nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MR (September 17, 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)