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Recall Observatory FDA recall evidence

Device product

nordicBrainEX, software versions 2.21 through 2.3.10

Z-1462-2022

June 16, 2022

Class II

Product summary

Firm
NordicNeuroLab AS
Event
Event 90480
Status
Terminated
Classification
Class II
Quantity
243 units
Official record key
device-enforcement:Z-1462-2022

Official wording

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.

Code information: UDI 07090042059015, software versions 2.21 through 2.3.10

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.