FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

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Products

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 provid
Brand
Microsoft Corporation Health Solutions Group
UPC
Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), including subsequent R2 release, Service Packs (SP)1, SP2, SP3.

Units Affected

13 units

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