Events

Retiro De Equipo (Recall) de Getinge Steriliser

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge 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-2018-RN-00196-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-21
  • 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-2018-RN-00196-1
  • 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
    Getinge has been made aware that certain gss67 sterilizers will not work up to specification due to power supply electrical connection issues. to date, no adverse events have been reported in australia.
  • Acción
    Getinge is providing affected users with an upgraded installation manual, service manual and electrical diagrams. For devices shipped prior to 2017 the electrical components of the device will be corrected. Devices shipped after 2017 have already had these components installed.

Device

Getinge Steriliser
  • Modelo / Serial
    Getinge Steriliser Model Number: GSS67HARTG Number: 139140Getinge Australia - Sterilizer, moist heat, wrapped goods
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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