Events

Retiro De Equipo (Recall) de IMPAX RIS 5.8 and higher (Picture archiving and communication system software)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AGFA HealthCare Australia.

¿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
    RC-2014-RN-00459-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-17
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00459-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    When batch printing is used to patient reports in qdoc, incorrect patient or referring physician information may be printed on reports. this issue occurs when the microsoft word background printing mechanism is used to send/spool to the printer.This recall action was carried out prior to the notification of the recall strategy to the tga.
  • Acción
    Customers are advised to disable the default background printing for IMPAX RIS by following the instructions in the customer letter. Changing this setting does not influence background printing from other applications.

Device

IMPAX RIS 5.8 and higher (Picture archiving and communication system software)
  • Modelo / Serial
    IMPAX RIS 5.8 and higher (Picture archiving and communication system software)ARTG Number: 120846
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia