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.
Reported: June 13, 2018 Initiated: September 17, 2014 #Z-2050-2018
Product 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 for Recall
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.
Details
- Recalling Firm
- NordicNeuroLab AS
- Units Affected
- 22 licenses
- Distribution
- USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
- Location
- Bergen, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by NordicNeuroLab AS. Units affected: 22 licenses.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2050-2018.
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