Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1082-2012

Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009

Microsoft Corporation Health Solutions Group / initiated 2012-01-04 / Terminated / root cause: software

Microsoft Corporation Health Solutions Group began a recall of Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009 Product Usage: Microsoft Amalga UIS 2009 enables healthcare... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1082-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Microsoft Corporation Health Solutions Group
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.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag
software
FDA root cause
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.
Product codes and lots
Software Version: R2 SP2, RTM, R2 SP3