Z-2243-2012Class III

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

Name: Z-2243-2012 Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting
Creator: Sunquest Information Systems, Inc.
Published: 2009-04-13
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2009-04-13 / Terminated / root cause: software

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting on 2009-04-13. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2243-2012
Classification: Class III
Status: Terminated
Initiated: 2009-04-13
Posted: 2012-08-22
Terminated: 2012-08-22
Recalling firm: CliniSys, Inc
Product: Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Sunquest, sent a "Urgent-Product Safety Notice: PSN-09-01" letter dated April 13, 2009 all their customers who purchase the Sunquest Encompass versions 2.4 and later. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to request software correction and to create a service request via client support webpage at www.sunquestinfo.com/supportweb. Then choose Submit a Service Request. Select Issue Type and select Software Request. When Software Request is selected, the Work Queue field automatically fills in with "Software Request." Promptly advise appropriate personnel. Customers with questions can contact Client Support and Services at (877) 239-6337 for US and Canadian sites and at +44(0)0800-960-972 for international sites.
Quantity in commerce: 23 clients
Distribution: Worldwide distribution: USA (nationwide) and country of: Bahamas.
Product codes and lots: versions 2.4 and later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2243-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-22

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)