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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78466

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 17, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
NordicNeuroLab AS

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2050-2018
Recall number
Z-2050-2018
Initiated
September 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
NordicNeuroLab AS
Quantity
22 licenses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

version 2.1 and older

Distribution pattern

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