Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1191-2012

Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS), Calculator/data processing...

Microsoft Corporation Health Solutions Group / initiated 2012-01-11 / Terminated / root cause: software

Microsoft Corporation Health Solutions Group began a recall of Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS), Calculator/data processing module, for clinical use. Microsoft Amalga UIS 2009... on . The reason FDA records is "The problem occurs when a user filters the data in Amalga datagrid to exclude specific values. If the field specified in the filter criteria contains NULL values, the filtering will exclude those records as well". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1191-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Microsoft Corporation Health Solutions Group
Product
Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS), 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
The problem occurs when a user filters the data in Amalga datagrid to exclude specific values. If the field specified in the filter criteria contains NULL values, the filtering will exclude those records as well.
Root cause tag
software
FDA root cause
Software design
Action
Microsoft Corporation Health Solutions Group sent a "Urgent Field Safety Notice" email dated January 19, 2012, to all affected customers. Notification of customers in China is still pending due to the Chinese New Year Holiday. Customers were instructed to : 1. If the user notices varying row counts or inconsistent values in a given column and they are using the exclude filter, they may have to look for alternative ways to filter the data that do not use the above mentioned filter conditions. 2. To avoid the indicated issue in your implementation there are two steps to be taken: a. Ensure that all parsers are inserting empty strings () rather than NULL when ingesting data into the system and b. Identify all Baseview definitions (i.e. the sql view that a baseview is accessing) that include an outer join and update those definitions to include the ISNULL replacement function [e.g. ISNULL( column_name, )] on any columns which may return NULL due to a non-matching row in the outer join tab As of January 23, 2012 The firm's members of Services Team have spoken by phone with representative of every customer. Customers should call 425-882-8080 for any questions about this recall.
Quantity in commerce
28 units
Distribution
Worldwide Distribution -- USA (nationwide) including the states of AR, CA, KY, HI, FL, MA, MD, MN, NC, NJ, NY, WA, WI and countries China, Switzerland, and United Kingdom.
Product codes and lots
2009; R2; R2 SP1; R2 SP2, R2 SP3, RTM.