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Terminated

nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

FDA Recall Z-2050-2018 · Posted None

Recalling FirmNordicNeuroLab AS
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-09-17
Date Terminated2021-03-24
Product Quantity22 licenses

Reason for Recall

An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.

Firm Action

The firm notified their consignees by email on 09/17/2014.

Root Cause

Software design

Distribution Pattern

USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom

Official Source

View FDA Recall →

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

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