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U.S. Department of Health and Human Services

Class 3 Device Recall Sunquest Encompass

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  Class 3 Device Recall Sunquest Encompass see related information
Date Initiated by Firm April 13, 2009
Date Posted August 22, 2012
Recall Status1 Terminated 3 on August 22, 2012
Recall Number Z-2243-2012
Recall Event ID 62751
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Sunquest Encompass

The reporting site is using the Encompass software in an acute patient care setting.
Code Information versions 2.4 and later
Recalling Firm/
Sunquest Information Systems, Inc.
250 S Williams Blvd
Tucson AZ 85711-4472
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.