Events

Retiro De Equipo (Recall) de Device Recall Sunquest Laboratory

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
    Recall
  • ID del evento
    63369
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0250-2013
  • Fecha de inicio del evento
    2011-11-03
  • Fecha de publicación del evento
    2012-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113605
  • 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
    Sunquest is recalling sunquest laboratory version 7.0 because when saving an accession to a non-current episode/event, a user-defined field can be incorrectly replaced by the current episode/event user-defined data.
  • Acción
    Sunquest Information Systems, Inc. sent a recall letter dated November 3, 2011, to all affected customers. Customers were informed of the problem identified and the actions to be taken. Customers were informed that a change request CR11-00174907 has been created to address this issue. This will be available as part of Sunquest Laboratory version 7.0.1. To request the software correction, customers were instructed to create a Case via the Client Support webpage at www.sunquestinfo.com/supportweb. Then choose a new case, and finally select work queue and select software request. Customers with questions were instructed to call (877) 239-6337 for US and Canadian sites and at +44 (0) 161 335 0562 for international sites. For questions regarding this recall call 520-570-2252.

Device

Device Recall Sunquest Laboratory

Manufacturer

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