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NordicNeuroLab AS recalls nordicBrainEX, software versions 2.21 through 2.3.10
Recalled August 3, 2022 · FDA recall Z-1462-2022 · 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. · FDA Class II
Units
243 units
Sold at
US Nationwide distribution.
Description
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.
Product
nordicBrainEX, software versions 2.21 through 2.3.10
Manufacturer(s)
NordicNeuroLab AS
Made in
Norway
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →