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U.S. Department of Health and Human Services

Class 3 Device Recall Microsoft Amalga UIS 2009

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  Class 3 Device Recall Microsoft Amalga UIS 2009 see related information
Date Initiated by Firm April 12, 2012
Date Posted June 04, 2012
Recall Status1 Terminated 3 on December 12, 2012
Recall Number Z-1702-2012
Recall Event ID 61673
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use.

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 Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), including subsequent R2 release, Service Packs (SP)1, SP2, SP3.
Recalling Firm/
Manufacturer		 Microsoft Corporation Health Solutions Group
14870 NE 31st Way
Redmond WA 98052
For Additional Information Contact Vlad Pigin
425-704-9813
Manufacturer Reason
for Recall		 Microsoft Amalga UIS 2009 has an issue with the display of lab results in the Lab Details window of the lab result viewer. The Lab Details view does not freeze/pin the row header when the user scroll horizontally.
FDA Determined
Cause 2		 Software design
Action Microsoft Corporation Health Solutions Group sent an "URGENT FIELD SAFETY NOTICE" dated April 12, 2012 to all affected customers via e-mail. The letter identifies the product, problem, and actions to be taken by the customers. The firm plans to revise its labeling for Amalga to clarify that the row headers will not be visible as the user scrolls horizontally. Customers were asked to complete and return to the firm a response form via fax at 425-706-7329 or e-mail to vlpigin@microsoft.com.
Quantity in Commerce 13 units
Distribution Worldwide Distribution-USA (nationwide) including the states of AR, MA, MD, NC, NY, and WA and the country of China.
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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