06

Jun

2018

Recall – Image Processing Software

0

Company: NordicNeuroLab AS
Date of Enforcement Report 6/6/2018
Class II:

PRODUCT
nordicBrainEXProduct 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. Recall Number: Z-2045-2018

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.

RECALLING FIRM/MANUFACTURER
NordicNeuroLab AS, Bergen Norway on 12/21/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
36 licenses

DISTRIBUTION
Nationwide and Internationally

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