FDA Medical Device Recalls (openFDA)
Microsoft Corporation Health Solutions Group: 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.
- Recall number
- Z-0507-2012
- 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.
- Status
- Terminated
- Initiated
- 2010-07-27
- Posted
- 2012-01-11
- Terminated
- 2011-12-20
- Reason
- 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
- 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 Michael.Stokes@microsoft.com.
- Quantity
- 1
- Distribution
- Nationwide Distribution -- Wisconsin.
- Lot, serial or model codes
- WHIE Implementation v1.1i
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3007734659
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28