BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1702-2012 · Initiated April 12, 2012

    Recall

    Recall Number
    Z-1702-2012
    Event Number
    61673
    Firm
    Microsoft Corporation Health Solutions Group
    FEI Number
    3007734659
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 12, 2012
    Posted
    June 4, 2012
    Terminated
    December 12, 2012
    Address
    14870 NE 31st Way, Redmond, WA, 98052

    Description

    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.

    Reason

    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.

    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 [email protected].

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AR, MA, MD, NC, NY, and WA and the country of China.

    Quantity

    13 units