Events

Retiro De Equipo (Recall) de Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and specific manufacturing lots of 3 focal spot x-ray tube (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-01035-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-25
  • 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-01035-1
  • 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 a potential problem with the artis zee and artis zeego systems with the a100 generator and specific lots of a 3 focal spot x-ray tube. the “small focus” of a 3 focal spot x-ray tube may sporadically fail if the case grounding detaches from the focus head and overheating occurs. further radiation release won’t be possible. an ongoing procedure can be continued by using one of the two remaining focal spots ("large focus” or "micro focus") instead. to achieve that, the operator will need to switch over to the other focus, thus causing a short interruption of the ongoing procedure.
  • Acción
    Siemens is implementing a software update that will protect the affected component from any damage in case the grounding detaches from the focus head. In case of such a potential failure, the system will automatically switch to the "Large Focus”. This action has been closed-out on 07/06/2016.

Device

Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and s...
  • Modelo / Serial
    Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and specific manufacturing lots of 3 focal spot x-ray tube (fluoroscopic angiographic x-ray system)ARTG number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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