Recall Z-2044-2018 ยท LLZ System, Image Processing, Radiological
NordicNeuroLab AS
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
| Date | Sep 12, 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 e-mail on 09/12/2014. Customers were informed of the reason for the recall, when the problem occurs, and what actions to take. Customers can perform a simple test by checking to see if there is a mismatch. Also, it is recommended that customers using BOLD and DTI, or other functionalities or workflows involving MPR switch to nordicBrainEx. Questions should be directed to NordicNeuroLab Customer Service at customerservice@nordicneurolab.com or 1-262-337-2909. |
| Quantity | 97 licenses |
| Distribution | Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082441 | NORDICICE SOFTWARE Nordicimaginglab AS, Nov 21, 2008 |