NordicNeuroLab AS: Medical Device Recall in 2022 - (Recall #: Z-1462-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

nordicBrainEX, software versions 2.21 through 2.3.10

Product Classification:

Class II

Date Initiated: June 16, 2022

Date Posted: August 3, 2022

Recall Number: Z-1462-2022

Event ID: 90480

Reason for Recall:

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.

Status: Terminated

Product Quantity: 243 units

Code Information:

UDI 07090042059015, software versions 2.21 through 2.3.10

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated