Exact FDA event identifier

Event 86995

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

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Event summary

Timeline bucket: December 14, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Brainreader ApS

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

Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images.

Z-0934-2021

Recall number: Z-0934-2021
Initiated: December 14, 2020
Classification: Class II
Status: Terminated
Recalling firm: Brainreader ApS
Quantity: 43 sites have had access

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.

Code information

Version 2.4

Distribution pattern

US Nationwide distribution including in the states of UT, PA, FL, AL, CA, MN, MD, MO, VA, DC, IL, TX, TN, MI, NY, IN, WA, WI, GA, MA.