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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80896

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

Open FDA event record

Event summary

Timeline bucket
August 28, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hitachi Healthcare Americas Corp Informatics Division

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

VidiStar(TM) PACS & DICOM Viewer Software system

Z-2992-2018
Recall number
Z-2992-2018
Initiated
August 28, 2018
Classification
Class II
Status
Terminated
Quantity
12 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software used in the interface between the Vidistar PACS and an EHR system may cause

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.

Code information

versions 3.10.5 and 3.10.6

Distribution pattern

SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA

Field note

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