Events

Retiro De Equipo (Recall) de Allersearch Economist Forte Nebuliser (non heated nebuliser)

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

¿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-2012-RN-00764-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-06
  • 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-2012-RN-00764-3
  • 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
    It is recongnised that there is an issue with the economist forte and the fit to the unit with the supplied power cord accessory. in some cases, the power cord moulding is too large to fit into the unit. it is necessary to state that there is no safety issue with the unit, other than the possibility of the device not working due to lack of power supply.
  • Acción
    The sponsor is asking pharmacies to return all affected stock to their wholesaler. The sponsor is asking all wholesalers to quarantine affected stock for return.

Device

Allersearch Economist Forte Nebuliser (non heated nebuliser)
  • Modelo / Serial
    Allersearch Economist Forte Nebuliser (non heated nebuliser)Catalogue Number: AE650-040Batch Numbers: 11AD12 and 11AD12AARTG Number: 98386
  • Manufacturer
    Ebos Group Pty Limited

Manufacturer

Ebos Group Pty Limited