Data Foundry

Medical device recalls 2012

Sunquest Encompass The reporting site is using the Encompass software… — Class III medical device recall Z-2243-2012

Terminated recall by Sunquest Information Systems, Inc., reported 2012-08-29, distributed nationwide. Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displ

Recall numberZ-2243-2012
Product typeMedical device
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSunquest Information Systems, Inc., Tucson, AZ, United States
Recall initiated2009-04-13
Classified2012-08-22
Reported by FDA2012-08-29
Terminated2012-08-22
DistributedNationwide (US)
Countries outside the USBS
Quantity23 clients

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2243-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.