Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0507-2012

Microsoft Amalga Unified Intelligence System (UIS), This is a software-only device, WHIE Implementation...

Microsoft Corporation Health Solutions Group / initiated 2010-07-27 / Terminated / root cause: software

Microsoft Corporation Health Solutions Group began a recall of Microsoft Amalga Unified Intelligence System (UIS), This is a software-only device, WHIE Implementation v1.1i. A calculator/data processing module, for... on . The reason FDA records is "The database may incorrectly match patient data resulting in the incorrect patient data being displayed. This could potentially present a risk to patient safety". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0507-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Microsoft Corporation Health Solutions Group
Product
Microsoft Amalga Unified Intelligence System (UIS), This is a software-only device, WHIE Implementation v1.1i. A calculator/data processing module, for clinical use. Intended to provide the clinical user with the ability to view data from multiple, different data systems.
Product code
JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall
The database may incorrectly match patient data resulting in the incorrect patient data being displayed. This could potentially present a risk to patient safety.
Root cause tag
software
FDA root cause
Software design
Action
Microsoft notified the sole consignee by FAX on 7/22/2010 with an Urgent Medical Device Safety Information. The letter identified the affected product, the description of the problem, and actions to be taken to correct the problem, along with some additional information for the consignee. In the interim, the firm proposes to block access to patient records identified as mismatched. The firm also stated that the issue has been addressed in version 2.0. The customer should report any incidents to Michael Stokes, Director of Policy Compliance at 208-938-5397 or via e-mail at [email protected].
Quantity in commerce
1
Distribution
Nationwide Distribution -- Wisconsin.
Product codes and lots
WHIE Implementation v1.1i