FDA Recall
Terminated
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.
Recall: Z-2050-2018
·
Initiated September 17, 2014
Recall
- Recall Number
- Z-2050-2018
- Event Number
- 78466
- Firm
- NordicNeuroLab AS Mollendalsveien 65c Bergen Norway
- FEI Number
- 3006738448
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- September 17, 2014
- Terminated
- March 24, 2021
Description
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.
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.
Action
The firm notified their consignees by email on 09/17/2014.
Distribution
USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
Quantity
22 licenses