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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86494

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

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Event summary

Timeline bucket
September 11, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fujifilm Medical Systems U.S.A., Inc.

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

Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

Z-0282-2021
Recall number
Z-0282-2021
Initiated
September 11, 2020
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.

Code information

Synapse Software Version 5.6.1

Distribution pattern

US Nationwide distribution including in the state of Minnesota.