Company:Microsoft Amalga
Date of Enforcement Report 3/14/12
Class ll:

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. Recall # Z-1082-2012

REASON
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.

RECALLING FIRM/MANUFACTURER
Microsoft Corporation Health Solutions Group, Redmond, WA, letter dated January 5, 2012. Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9 units

DISTRIBUTION
Nationwide