Retiro De Equipo (Recall) de Hospital Information System Results Reporting Interface Versions,,,

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 SCC Soft Computer.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Medical computers and software - Product Code LNX
  • Causa
    Scc soft computer, clearwater, fl issued a correction for hospital information system results reporting interface versions,,, and on 10/05/2007. a software anomaly in the result reporting interface caused result comments entered after an empty line not to be sent to the his system. this included interpretative comments, results, and normal range c.
  • Acción
    SCC Soft Computer sent a RISK-TO-HEALTH NOTIFICATION TASK VERBIAGE dated October 5, 2007, through their Task Management System to all affected clients on October 17, 2007. The notice identified the product, the problem and the action clients should take to correct the problem. Clients were to acknowledge receipt of the task notice and to identify if the Workflow or functionality is not used and if they Agree to use alternative working solutions. Each client was asked to grant permission to load the required software to correct the issue. For any questions regarding this recall call (727) 789-0100.


  • Modelo / Serial
    Versions,,, and
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the country of Canada
  • Descripción del producto
    Hospital Information System Results Reporting Interface Versions,,, and || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Dates: || 06/15/07 || 06/29/07, || 07/19/07, || 08/20/07. || The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.
  • Manufacturer


  • Dirección del fabricante
    SCC Soft Computer, 5400 Tech Data Drive, Clearwater FL 33760
  • Empresa matriz del fabricante (2017)
  • Source