Events

Retiro De Equipo (Recall) de Axiom Artis and Artis Zee Systems with hand switch (Fluoroscopic angiographic X-ray 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 Siemens 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-00648-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-17
  • 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-00648-1
  • 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
    A problem may occur if the connection between cable connection and hand switch is contaminated with a large amount of fluid. in a worst case situation, uncontrolled release of a x-ray image may happen. the system terminates uncontrolled x-ray after a short period.
  • Acción
    Siemens service personnel will contact affected customers to organise for the removal of the cable extension. The hand switch will be directly connected to the patient table preventing the issue from occurring.

Device

Axiom Artis and Artis Zee Systems with hand switch (Fluoroscopic angiographic X-ray system)
  • Modelo / Serial
    Axiom Artis and Artis Zee Systems with hand switch (Fluoroscopic angiographic X-ray system)Hand Switch Material Number: 3771750 ARTG Numbers: 102173 and 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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