FDA-Device2022-08-03Class II
nordicBrainEX, software versions 2.21 through 2.3.10
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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