Retiro De Equipo (Recall) de Sunquest Laboratory System.

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 Sunquest Information Systems, Inc..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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. - Product Code JQP
  • Causa
    While performing in-house testing for the sunquest laboratory system and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (cache)was not communicated or displayed in the graphic user interface (gui) application so the activity continued. while this error was registered in the error log in the system u.
  • Acción
    A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.


  • Modelo / Serial
    Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.
  • Descripción del producto
    Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. || The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.
  • Manufacturer


  • Dirección del fabricante
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • Empresa matriz del fabricante (2017)
  • Source