Events

Retiro De Equipo (Recall) de Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray 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-2016-RN-00375-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-31
  • 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-2016-RN-00375-1
  • 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
    The manufacturer, through post market surveillance, has identified the following problems with the affected devices:a) in artis zeego systems, angulations in the vicinity of the c-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. b) in artis systems with a100plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator, which can lead to system non-availability.The reported issues can cause an ongoing procedure to be terminated.
  • Acción
    Siemens service organisation will contact the affected customers to arrange for the installation of a software update, which will eliminate the reported problems.

Device

Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fl...
  • Modelo / Serial
    Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems) Catalogue/Lot numbers: 10280959, 10094139, 10094135, 10094137, 10094141ARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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