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U.S. Department of Health and Human Services

Class 2 Device Recall Microsoft Amalga Unified Intelligence System

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  Class 2 Device Recall Microsoft Amalga Unified Intelligence System see related information
Date Initiated by Firm January 04, 2012
Date Posted February 22, 2012
Recall Status1 Terminated 3 on December 12, 2012
Recall Number Z-1082-2012
Recall Event ID 60890
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009

Product Usage:
Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs.
Code Information Software Version: R2 SP2, RTM, R2 SP3  
Recalling Firm/
Manufacturer		 Microsoft Corporation Health Solutions Group
14870 NE 31st Way
Redmond WA 98052
For Additional Information Contact
425-722-1449
Manufacturer Reason
for Recall		 Healthcare providers reported that when sharing a single browser session on Amalga Web, patient A's data can be displayed under patient B's name.
FDA Determined
Cause 2		 Software design
Action Microsoft Corporation sent an "Urgent Field Safety Notice" letter dated January 5, 2012 by email to all affected customers. The letter described the product, problem, and actions to be taken by the customers. If you have any questions about this corrective action program, please contact Microsoft Corporation at 425-882-8080.
Quantity in Commerce 9 units
Distribution Worldwide Distribution - USA (nationwide) including the states of California, China, Kentucky, North Carolina, Wisconsin and country of Switzerland.
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.
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