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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62751

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

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Event summary

Timeline bucket
April 13, 2009
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sunquest Information Systems, 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

Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

Z-2243-2012
Recall number
Z-2243-2012
Initiated
April 13, 2009
Classification
Class III
Status
Terminated
Quantity
23 clients

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.

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

Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.

Code information

versions 2.4 and later

Distribution pattern

Worldwide distribution: USA (nationwide) and country of: Bahamas.