Events

Retiro De Equipo (Recall) de Device Recall SoftPath GUI Releases 3.17 through 4.1.0.

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
    56275
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0067-2011
  • Fecha de inicio del evento
    2007-03-28
  • 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=93117
  • 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 softpath gui releases 3.17 and 4.1 in march 2007 for clients with high volume output of final reports who use the batch print for final reports in the scheduler, there is a potential for some reports not printing. this issue was corrected for the one affected user in october 2003.
  • Acción
    SCC Soft Computer sent a SAFETY NOTIFICATION TASK VERBIAGE dated January 5, 2004, to one client. The Notice identified the product, the problem, and the action to be taken by the client. SCC recommended the client set the Search Date Range to a small enough range to assure that the number of cases scanned during the job would be less than 10,000. The client was asked to acknowledge receipt of the task and to indicate if the Workflow or functionality was used/not used and Agree to use the alternative working solution. For any questions regarding this recall call (727) 780-0100, ext. 4235.

Device

Device Recall SoftPath GUI Releases 3.17 through 4.1.0.
  • Modelo / Serial
    Versions 3.17.5, 3.17.6, 3.17.7, 3.17.8, 4.1.0, and 4.1.1.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide - USA, including the states of CA, CO, CT, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, SD, TX, WI, and WV
  • Descripción del producto
    SoftPath GUI Releases 3.17 through 4.1.0. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Manufacture/Distribution Dates: || Version 3.17.5 10/14/2003. || Version 3.17.6 03/28/2003. || Version 3.17.7 07/02/2003. || Version 3.17.8 03/03/2004. || Version 4.1.0 07/03/2003. || Version 4.1.1 10/03/2003. || Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.
  • 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