Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90480

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

Open FDA event record

Event summary

Timeline bucket
June 16, 2022
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, software versions 2.21 through 2.3.10

Z-1462-2022
Recall number
Z-1462-2022
Initiated
June 16, 2022
Classification
Class II
Status
Terminated
Recalling firm
NordicNeuroLab AS
Quantity
243 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

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

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.

Code information

UDI 07090042059015, software versions 2.21 through 2.3.10

Distribution pattern

US Nationwide distribution.