Events

Retiro De Equipo (Recall) de Device Recall Microsoft Amalga Unified Intelligence System (UIS)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Microsoft Corporation Health Solutions Group.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56545
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0507-2012
  • Fecha de inicio del evento
    2010-07-27
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93895
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    The database may incorrectly match patient data resulting in the incorrect patient data being displayed. this could potentially present a risk to patient safety.
  • Acción
    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.

Device

Device Recall Microsoft Amalga Unified Intelligence System (UIS)
  • Modelo / Serial
    WHIE Implementation v1.1i
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- Wisconsin.
  • Descripción del producto
    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.
  • Manufacturer
    Microsoft Corporation Health Solutions Group

Manufacturer

Microsoft Corporation Health Solutions Group
  • Dirección del fabricante
    Microsoft Corporation Health Solutions Group, 14870 NE 31st Way, Redmond WA 98052
  • Source
    USFDA