Recall Z-2042-2018 ยท LLZ System, Image Processing, Radiological
NordicNeuroLab AS
nordicTumorEx 1.0 nordicTumorEx 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 moda
| Date | Dec 15, 2014 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | The firm notified their consignees of the software problem by email on December 14, 2014. For further questions please call (262) 337-2909. |
| Quantity | 16 licenses |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123306 | NORDIC TUMOREX Nordicneurolab, May 20, 2013 |