Recall Z-2050-2018— NordicNeuroLab AS
Class II · Terminated
Class II FDA medical device recall by NordicNeuroLab AS, initiated 2014-09-17, terminated 2021-03-24. It names one FDA 510(k) clearance: K133910. Product: 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..
- Recalling firm
- NordicNeuroLab AS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-17
- Terminated
- 2021-03-24
- Firm location
- Bergen, N/A, Norway
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.