Events

Retiro De Equipo (Recall) de Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.

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
    56872
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0362-2011
  • Fecha de inicio del evento
    2010-06-22
  • Fecha de publicación del evento
    2010-11-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94757
  • 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
    Software, blood bank, stand alone products - Product Code MMH
  • Causa
    Scc soft computer is issuing a correction for softbank ii versions: 23.1.2.X, 23.2.0.X, and 25.0.0.X software applications. functionality issue - for clients generating patient history reports using patient>reports>batch reports>history report option in softbank with softreports activated for patient reports, when the report is generated for more than one patient all of the results for the qualif.
  • Acción
    SCC Soft Computer notified Customers on June 22, 2010, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated June 11, 2010. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; to grant permission to load the required hot fix, and to make the manual correction. For the manual correction to the datapath for patient report layouts, your SoftBank Support Specialist will Coordinate those changes and your validation of affected environments. If you have any questions, contact (727) 789-0100.

Device

Device Recall SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.
  • Modelo / Serial
    Versions 23.1.2.x, 23.2.0.x, 25.0.0.x
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: U.S. and country of Canada.
  • Descripción del producto
    SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || 23.1:BK040048 || 23.2:BK080020 || 25.0:BK090017 || The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and multiple site facilities the ability to manage their transfusion service by integrating patient and unit information. SoftBank uses an SCC proprietary interface called SoftScape that facilitates access to the application.
  • 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