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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78848

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

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Event summary

Timeline bucket
October 28, 2017
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

fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.

Z-2103-2018
Recall number
Z-2103-2018
Initiated
October 28, 2017
Classification
Class II
Status
Terminated
Recalling firm
NordicNeuroLab AS
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

Code information

HPS-2015-1.0-XXX HPS-2016-1.0-XXX

Distribution pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria