FDA Recall Terminated

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

Recall: Z-2243-2012 · Initiated April 13, 2009

Recall

Recall Number
Z-2243-2012
Event Number
62751
Firm
Sunquest Information Systems, Inc.
FEI Number
1000306472
Product Code
JQP
Status
Terminated
Root Cause
Software design
Initiated
April 13, 2009
Posted
August 22, 2012
Terminated
August 22, 2012
Address
250 S Williams Blvd, Tucson, AZ, 85711-4472

Description

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

Reason

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.

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.

Distribution

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

Quantity

23 clients