FDA Medical Device Recalls (openFDA)
NordicNeuroLab AS: nordicBrainEX Product Usage: nordicBrainEx 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.
- Recall number
- Z-2045-2018
- Recalling firm
- NordicNeuroLab AS
- Product
- nordicBrainEX Product Usage: nordicBrainEx 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.
- Status
- Terminated
- Initiated
- 2012-12-21
- Posted
- not on file
- Terminated
- 2020-09-16
- Reason
- There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B.
- Root cause
- Software design
- Action
- The firm distributed the recall notification letter by email. The letter identified the affected product, problem and the actions to be taken. For questions contact NordicNeurolab Customer Service or if you would like to arrange a return customerservice@nordicneurolab.com.
- Quantity
- 36 licenses
- Distribution
- Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan
- Lot, serial or model codes
- version 1.1.2
- 510(k) numbers
- ["K092102"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3006738448
- Firm city
- Bergen
- Firm state
- not on file
- Firm country
- Norway
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28