Events

Retiro De Equipo (Recall) de Wireless Foot Switch - Artis systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2017-RN-00325-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-08
  • 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-2017-RN-00325-1
  • 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
    Siemens has identified an issue whereby the gap in the housing of the wireless foot switch can result in liquids penetrating the interior. liquids may include disinfection and cleaning agents as well as bodily fluids. this can result in the failure of the foot switch. if the foot switch fails, it will no longer be possible to use it to release radiation. the hand switch provided can still be used to release exposures, but fluoroscopic examinations will not be possible. consequently, a situation may arise whereby it is necessary to cancel or restart clinical treatment or to transfer treatment to a functioning system.
  • Acción
    Siemens is currently working on a solution which is expected during the second quarter of 2017. Siemens generally recommend the use of sterile covers to protect the foot switch from all types of contamination. This is an effective way to prevent the foot switch from coming into contact with liquids. In the event of foot switch failure, users are further advised that the release of radiation for imaging purposes is still possible using the hand switch. Users are to note that standard emergency processes should be in place and ready for implementation until corrective actions are carried out.

Device

Wireless Foot Switch - Artis systems
  • Modelo / Serial
    Wireless Foot Switch - Artis systemsCatalogue Numbers: 4787797, 4787805, 4787813(Artis Systems supplied after 01 January 2005)ARTG Number: 145549
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA