Class 2 Device Recall Microsoft Amalga UIS 2009

• Date Initiated by Firm: January 11, 2012
• Date Posted: March 08, 2012
• Recall Status: Terminated on December 12, 2012
• Recall Number: Z-1191-2012
• Recall Event ID: 61021
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• 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.
• Code Information: 2009; R2; R2 SP1; R2 SP2, R2 SP3, RTM.
• Recalling Firm/ Manufacturer: Microsoft Corporation Health Solutions Group; 14870 NE 31st Way; Redmond WA 98052
• For Additional Information Contact: 425-882-8080
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.