Retiro De Equipo (Recall) de Zymed Holter Converter (Cardiology information system designed for the collection and management of electrocardiography data)

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

¿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-2013-RN-01361-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-10
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    There is a potential problem with the zymed holter converter if more than one instance of the program was inappropriately started, the pdf image for patient could be generated incorrectly.This recall action was undertaken prior to agreement of the recall strategy by the tga.
  • Acción
    Epiphany Healthcare (the manufacturer) installed a software patch to correct the software error.

Device

  • Modelo / Serial
    Zymed Holter Converter (Cardiology information system designed for the collection and management of electrocardiography data)ARTG number: 171621
  • Manufacturer

Manufacturer