Events

Retiro De Equipo (Recall) de Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1,

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
    Recall
  • ID del evento
    56278
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0069-2011
  • Fecha de inicio del evento
    2007-10-05
  • Fecha de publicación del evento
    2010-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93123
  • 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 4.0.2.38.1, 4.0.2.39.2, 4.0.2.40.1, and 4.0.2.41.1 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.

Device

Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1,
  • Modelo / Serial
    Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • 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 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Dates: || 4.0.2.38.1 06/15/07 || 4.02.39.2 06/29/07, || 4.02.40.1 07/19/07, || 4.02.41.1 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
    SCC Soft Computer

Manufacturer

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