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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76309

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

Open FDA event record

Event summary

Timeline bucket
April 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merge Healthcare, 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

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

Z-1681-2017
Recall number
Z-1681-2017
Initiated
April 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
Merge Healthcare, Inc.
Quantity
1,627 sites potentially have the affected software

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.

Code information

All versions of Eye Care PACS, Eye Station, and ESIU.

Distribution pattern

Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.

Field note

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