Reported Aug 3, 2022 · Terminated
nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NordicNeuroLab AS · Mollendalsveien 65c · Bergen · N/A
Is this the product you have?
- nordicBrainEX, software versions 2.21 through 2.3.10
- Lot codes and dates
UDI 07090042059015software versions 2.21 through 2.3.10
- Amount recalled
- 243 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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