Recall Z-0507-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use
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.
| Date | Jan 11, 2012 (initiated Jul 27, 2010) |
| Status | Terminated |
| 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@mi |
| Quantity | 1 |
| Distribution | Nationwide Distribution -- Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.