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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76401

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 Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

Z-1415-2017
Recall number
Z-1415-2017
Initiated
April 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
Merge Healthcare, Inc.
Quantity
17 sites potentially have the affected versions

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

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

A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

Code information

Version 9.0.9 and earlier using EchoIMS.

Distribution pattern

US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.