Recall Z-2045-2018 ยท LLZ System, Image Processing, Radiological
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 device
| Date | Dec 21, 2012 |
| Status | Terminated |
| 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 position |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092102 | NORDICBRAINEX SOFTWARE, VERSION 1.0 Nordicimaginglab AS, Aug 25, 2009 |