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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: version 2.1 and older
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- NordicNeuroLab AS
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
version 2.1 and older
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2050-2018
Related Recalls
nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS
When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped.
Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.