Events

Retiro De Equipo (Recall) de Aeroneb Pro/Solo Nebuliser Systems FRIWO power adapter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Tag Medical 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-2014-RN-01003-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-18
  • 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-01003-1
  • 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
    Tag medical have been advised by aerogen ltd that there is a potential hazard with certain friwo power adaptors as supplied with the aerogen pro and aerogen solo nebuliser systems manufactured during the period of week 50/2013 and week 23/2014. the power adapter could potentially fail, whereby the plastic screw pillars can break and dislodge from the body and the adapter cover can open.
  • Acción
    Tag Medical is contacting the hospitals and replacing the faulty FRIWO power adaptors free of charge. This action has been closed-out on 06/06/2016.

Device

Aeroneb Pro/Solo Nebuliser Systems FRIWO power adapter
  • Modelo / Serial
    Aeroneb Pro/Solo Nebuliser Systems FRIWO power adapter Multiple catalogue numbers and date codes affectedARTG Number: 99080
  • Manufacturer
    Tag Medical Pty Ltd

Manufacturer

Tag Medical Pty Ltd