medical Class II Updated 2022-08-03

NordicNeuroLab AS recalls nordicBrainEX, software versions 2.21 through 2.3.10

Recalled Product

nordicBrainEX, software versions 2.21 through 2.3.10


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 07090042059015, software versions 2.21 through 2.3.10
View official government recall

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