Recall Z-2061-2018 ยท LLZ System, Image Processing, Radiological
NordicNeuroLab AS
nordicICE v 2.3.14 nordicICE 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 modaliti
| Date | Jul 3, 2015 |
| Status | Terminated |
| Reason | The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not be adjusted according to the coregistration. |
| Root cause | Software design |
| Action | The firm notified their customers by email on July 3, 2015. Actions to be taken by the customer/User: We advise users to immediately stop using the BOLD module in nordiclCE and contact NordicNeuroLab for further instructions on how to upgrade the nordiclCE BOLD module, as described more fully below. For further questions, please call (262) 337-2909. |
| Quantity | 121 licenses |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082441 | NORDICICE SOFTWARE Nordicimaginglab AS, Nov 21, 2008 |