FDA-Device2022-08-03Class II
nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
243 units
Manufactured in
Mollendalsveien 65c, Bergen, Norway
Products
nordicBrainEX, software versions 2.21 through 2.3.10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2022Don't want to check this manually?
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