NordicNeuroLab AS Recall 90480
Description: nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS Recall 90480 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1462-2022 |
| Event ID | 90480 |
| Event Description | nordicBrainEX, software versions 2.21 through 2.3.10 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 243 units |
| Recall 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. |
| Device Classification | 20220803 |
| Device Code Info | UDI 07090042059015, software versions 2.21 through 2.3.10 |
| Center Classification Date | 20220725 |
| Recall Initiation Date | 20220616 |
| Recalling Firm | NordicNeuroLab AS |
| Initial Notification | |
| Similar To |