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Terminated

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

FDA Recall Z-2243-2012 · Posted 2012-08-22

Recalling FirmSunquest Information Systems, Inc.
Recall StatusTerminated
Product CodeJQP
Date Initiated2009-04-13
Date Terminated2012-08-22
Product Quantity23 clients

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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