Product Safety Recalls

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NordicNeuroLab AS Recall 90480

Description: nordicBrainEX, software versions 2.21 through 2.3.10

NordicNeuroLab AS Recall 90480 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1462-2022
Event ID90480
Event DescriptionnordicBrainEX, software versions 2.21 through 2.3.10
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity243 units
Recall ReasonWhen 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.
Device Classification20220803
Device Code InfoUDI 07090042059015, software versions 2.21 through 2.3.10
Center Classification Date20220725
Recall Initiation Date20220616
Recalling FirmNordicNeuroLab AS
Initial Notification E-Mail
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