Z-1462-2022 Class II Terminated
FDA device recall Z-1462-2022 was initiated by NordicNeuroLab AS on June 16, 2022 and is designated Class II. 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 s… The recall status is terminated (terminated September 4, 2024). Affected quantity: 243 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- June 16, 2022
- Termination Date
- September 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 243 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI 07090042059015, software versions 2.21 through 2.3.10