Exact FDA event identifier

Event 74372

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

Open FDA event record

Event summary

Timeline bucket: May 10, 2016
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 version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.

Z-2043-2016

Recall number: Z-2043-2016
Initiated: May 10, 2016
Classification: Class II
Status: Terminated
Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Quantity: 27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

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

Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

Code information

Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020

Distribution pattern

US Distribution to states of: CA, FL, KS, NE, NY, and PA.