Events

Retiro De Equipo (Recall) de Device Recall SoftLab GUI versions 4.0.2.84.0.2.10; 4.0.3.124.0.3.13; and 4.0.4.14.0.4.4.

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
    60436
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0277-2012
  • Fecha de inicio del evento
    2011-05-03
  • Fecha de publicación del evento
    2011-11-23
  • 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=105402
  • 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
    On 05/03/2011 scc soft computer, clearwater, fl initiated a correction on the following softlab gui versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. a client reported the pt and inr results did not get flagged. the prot should have been flagged as high and the inr should have been flagged as panic. neither test was flagged. all affected clients were notified of the issue on 05/03.
  • Acción
    SCC Soft Computer initiated a Field correction on May 3, 2011. All customers with affected software have been notified of this issue. Clients were instructed to have a "valcheck" utility run to determine if there are any tests in their system affected by the issue. They were supposed to indicate whether they wanted to schedule to receive the patch or hot fix. If you have any further questions please call ( 727 ) 789-0100.

Device

Device Recall SoftLab GUI versions 4.0.2.84.0.2.10; 4.0.3.124.0.3.13; and 4.0.4.14.0.4.4.
  • Modelo / Serial
    SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-- USA ( nationwide) and Canada.
  • Descripción del producto
    SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data.
  • 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