Events

Retiro De Equipo (Recall) de Artis Q Systems with A100G generators

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-00303-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-02
  • 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-00303-1
  • 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
    In artis systems with a100g generators, a component can be affected by ageing, resulting in the failure of a module in the high-voltage generator. when the failure occurs, the system usually responds by providing emergency fluoroscopy. in the worst case, a spontaneous failure of the radiation generation function is conceivable. in the event of a spontaneous failure, it may be necessary to cancel or restart a clinical treatment or transfer it to a functioning system.
  • Acción
    Siemens is advising users that potentially affected modules will be replaced. Users are further advised to implement standard emergency processes in the event of a system failure and to have these processes carefully prepared until the affected modules are replaced.

Device

Artis Q Systems with A100G generators
  • Modelo / Serial
    Artis Q Systems with A100G generators Catalogue Numbers: 10848353, 10848354, 10848355, 10848280, 10848281, 10848282, 10848283ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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