Events

Retiro De Equipo (Recall) de Device Recall SoftPath GUI

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
    60420
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0209-2012
  • Fecha de inicio del evento
    2011-07-13
  • Fecha de publicación del evento
    2011-11-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105376
  • 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
    Soft computer, clearwater, fl, initiated a correction on the following softpath gui versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. softpath architecture does not correctly handle ap macros and data fields inside report sections that are stored in the database. improper information can be displayed in all places where the diagnosis from the database is read and displayed.
  • Acción
    The firm, SCC Soft Computer, sent a "CORRECTION COMMUNICATION" notice on July 13, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to restrict security access to the template set-up files and to acknowledge receipt of the notice; grant SCC personnel permission to check their report templates and correct any that are affected; indicate if they wish to schedule the utility to be run and if they would like to have the SoftWeb parameter PathPDFLinkOnly set to "Y". SCC will review the templates on the customers systems; discuss any irregularities requiring change and move or remove AP macros and data elements as needed. If you have any questions, contact the Director of Quality Management at (727)789-0100.

Device

Device Recall SoftPath GUI
  • Modelo / Serial
    SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AR, AL, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NH, NJ, NY, OH, OK, PA, SD, TX, VA, WA, WI, WV including Puerto Rico; country of Canada.
  • Descripción del producto
    SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. || SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.
  • 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