Events

Retiro De Equipo (Recall) de Microsoft Amalga UIS 2009

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
    61673
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1702-2012
  • Fecha de inicio del evento
    2012-04-12
  • Fecha de publicación del evento
    2012-06-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108695
  • 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
    Microsoft amalga uis 2009 has an issue with the display of lab results in the lab details window of the lab result viewer. the lab details view does not freeze/pin the row header when the user scroll horizontally.
  • Acción
    Microsoft Corporation Health Solutions Group sent an "URGENT FIELD SAFETY NOTICE" dated April 12, 2012 to all affected customers via e-mail. The letter identifies the product, problem, and actions to be taken by the customers. The firm plans to revise its labeling for Amalga to clarify that the row headers will not be visible as the user scrolls horizontally. Customers were asked to complete and return to the firm a response form via fax at 425-706-7329 or e-mail to vlpigin@microsoft.com.

Device

Microsoft Amalga UIS 2009
  • Modelo / Serial
    Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), including subsequent R2 release, Service Packs (SP)1, SP2, SP3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AR, MA, MD, NC, NY, and WA and the country of China.
  • Descripción del producto
    Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use. || Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs.
  • 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