Retiro De Equipo (Recall) de Device Recall 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
    61021
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1191-2012
  • Fecha de inicio del evento
    2012-01-11
  • Fecha de publicación del evento
    2012-03-08
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-12-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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 problem occurs when a user filters the data in amalga datagrid to exclude specific values. if the field specified in the filter criteria contains null values, the filtering will exclude those records as well.
  • Acción
    Microsoft Corporation Health Solutions Group sent a "Urgent Field Safety Notice" email dated January 19, 2012, to all affected customers. Notification of customers in China is still pending due to the Chinese New Year Holiday. Customers were instructed to : 1. If the user notices varying row counts or inconsistent values in a given column and they are using the exclude filter, they may have to look for alternative ways to filter the data that do not use the above mentioned filter conditions. 2. To avoid the indicated issue in your implementation there are two steps to be taken: a. Ensure that all parsers are inserting empty strings () rather than NULL when ingesting data into the system and b. Identify all Baseview definitions (i.e. the sql view that a baseview is accessing) that include an outer join and update those definitions to include the ISNULL replacement function [e.g. ISNULL( column_name, )] on any columns which may return NULL due to a non-matching row in the outer join tab As of January 23, 2012 The firm's members of Services Team have spoken by phone with representative of every customer. Customers should call 425-882-8080 for any questions about this recall.

Device

  • Modelo / Serial
    2009; R2; R2 SP1; R2 SP2, R2 SP3, RTM.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the states of AR, CA, KY, HI, FL, MA, MD, MN, NC, NJ, NY, WA, WI and countries China, Switzerland, and United Kingdom.
  • Descripción del producto
    Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS), 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

Manufacturer

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