Events

Retiro De Equipo (Recall) de SoftLab GUI Version 4.0.1.0 4.0.1.16, 4.0.2.0 4.0.2.10, 4.0.3.0 4.0.3.13, and 4.0.4.0 4.0.4.

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
    56867
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0365-2011
  • Fecha de inicio del evento
    2009-04-01
  • Fecha de publicación del evento
    2010-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94701
  • 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
    Clients using patient maintenance to perform moves of stays may send the wrong billing number during an adt update to softweb, softpath or softmedia. the wrong billing number can come from a different patient in order entry. only moves of stays are affected.
  • Acción
    Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.

Device

SoftLab GUI Version 4.0.1.0 4.0.1.16, 4.0.2.0 4.0.2.10, 4.0.3.0 4.0.3.13, and 4.0.4.0 4.0.4.
  • Modelo / Serial
    Versions: 4.0.1.0 - 4.0.1.16; 4.0.2.0 - 4.0.2.10; 4.0.3.0 - 4.0.3.13; and 4.0.4.0 - 4.0.4.5.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || 4.0.1.0 - 08/06/04, || 4.0.1.4 - 10/18/04, || 4.0.1.5 - 01/18/04, || 4.0.1.6 - 12/15/04, || 4.0.1.7 - 01/10/05, || 4.0.1.8 - 03/29/05, || 4.0.1.9 - 05/06/05, || 4.0.1.13 - 01/25/06, || 4.0.1.14 - 03/26/07 || 4.0.1.15 - 05/02/07, || 4.0.1.16 - 08/22/08, || 4.0.2.0 - 04/08/05, || 4.0.2.1 - 08/13/08, || 4.0.2.2 - 06/06/05, || 4.0.2.3 - 09/19/05, || 4.0.2.4 - 09/19/05, || 4.0.2.5 - 09/19/05, || 4.0.2.7 - 02/13/06, || 4.0.2.8 - 12/12/06, || 4.0.2.9 - 02/20/08, || 04.2.10 - 08/13/08, || 4.0.3.2 - 05/17/06, || 4.0.3.3 - 09/18/06, || 4.0.3.4 - 09/27/06, || 4.0.3.5 - 11/29/06, || 4.0.3.6 - 06/22/07, || 4.0.3.7 - 03/28/07, || 4.0.3.8 - 06/22/07, || 4.0.3.9 - 08/03/07, || 4.0.3.10 - 08/24/07, || 4.0.3.11 - 09/24/07, || 4.0.3.12 - 03/07/08, || 4.0.3.13 - 06/13/08, || 4.0.4.2 - 02/22/08, || 4.0.4.3 - 05/22/08, || 4.0.4.4 - 07/28/08, || 4.0.4.5 - 05/04/09. || Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.
  • 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