Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1702-2012

Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data...

Microsoft Corporation Health Solutions Group / initiated 2012-04-12 / Terminated / root cause: software

Microsoft Corporation Health Solutions Group began a recall of Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use. Microsoft... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1702-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Microsoft Corporation Health Solutions Group
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.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag
software
FDA root cause
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 [email protected].
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.
Product codes and lots
Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), including subsequent R2 release, Service Packs (SP)1, SP2, SP3.