Recall Z-2050-2018 ยท LLZ System, Image Processing, Radiological
NordicNeuroLab AS
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
| Date | Sep 17, 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 by email on 09/17/2014. |
| Quantity | 22 licenses |
| Distribution | USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133910 | NORDICBRAINEX Nordicneurolab, Apr 4, 2014 |