Retiro De Equipo (Recall) de Device Recall SoftReports versions 1.1.6.x and 1.1.7.x

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 is issuing a correction for softreports versions 1.1.6.X released 02/2008 and 1.1.7.X released 06/2008. potential hazard - when using softreports layout designer, results displayed in the report may not match the patient information in the report header.
  • Acción
    SCC Soft Computers sent a "RISK TO HEALTH NOTIFICATION TASK" letter dated June 9, 2010 to affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were offered an upgrade or hot fix. The letter requested acknowledgement of receipt of the task notification and permission to install the hot fix.


  • Modelo / Serial
    Versions 1.1.6.x and 1.1.7.x.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • Descripción del producto
    SoftReports versions 1.1.6.x and 1.1.7.x || SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).
  • Manufacturer


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