Recall Z-1462-2022— NordicNeuroLab AS
Class II · Terminated
Class II FDA medical device recall by NordicNeuroLab AS, initiated 2022-06-16, terminated 2024-09-04. It names one FDA 510(k) clearance: K133910. Product: nordicBrainEX, software versions 2.21 through 2.3.10. Reason: 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..
- Recalling firm
- NordicNeuroLab AS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-06-16
- Terminated
- 2024-09-04
- Firm location
- Bergen, 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, software versions 2.21 through 2.3.10
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.