Events

Retiro De Equipo (Recall) de Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2014-RN-00139-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-11
  • 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-00139-1
  • 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
    Stryker is implementing upgrades to the neptune 2 waste management system further to the previous recall for product correction in may 2013 (tga reference: rc-2013-rn-00265-1) where stryker received reports of serious injury or death in the usa due to the neptune 2 being connected to a passive chest drainage tube or closed wound drainage device post-operatively.
  • Acción
    Stryker is upgrading the Neptune 2 Rover Ultra units with a new top cap, labels and software package to mitigate the potential for incorrect use. Thia action has been closed-out on 28/01/2016.

Device

Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA