Microsoft Amalga Unified Intelligence System (UIS), This is a software-only device, WHIE Implementation v1.1i. A calcula

FDA device recall Z-0507-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Microsoft Corporation Health Solutions Group

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.

Action taken

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 Michael.Stokes@microsoft.com.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

1

Distribution

Nationwide Distribution -- Wisconsin.

Date initiated

2010-07-27

Date posted

2012-01-11

Date terminated

2011-12-20

Location

Redmond, WA