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Terminated

nordicBrainEX, software versions 2.21 through 2.3.10

FDA Recall Z-1462-2022 · Posted None

Recalling FirmNordicNeuroLab AS
Recall StatusTerminated
Product CodeLLZ
Date Initiated2022-06-16
Date Terminated2024-09-04
Product Quantity243 units

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.

Firm Action

The firm sent a notice regarding a Critical Bug in nordicBrainEx version 2.2.1 to 2.3.10 on 06/16/2022 by email. The notice explained the problem and advised users to use extra caution when viewing the exported results. A software revision will be released to correct the issue.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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