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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77271

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

Open FDA event record

Event summary

Timeline bucket
May 24, 2017
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 OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

Z-2601-2017
Recall number
Z-2601-2017
Initiated
May 24, 2017
Classification
Class II
Status
Terminated
Recalling firm
Merge Healthcare, Inc.
Quantity
160 sites potentially have the affected versions

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

Code information

Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2

Distribution pattern

USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.