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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87083

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

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Event summary

Timeline bucket
December 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

FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - 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-0918-2021
Recall number
Z-0918-2021
Initiated
December 11, 2020
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

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

The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

Code information

Versions 7.0.0 and 7.0.1

Distribution pattern

US Nationwide distribution in the state of MD.