Events

Retiro De Equipo (Recall) de Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)

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-2015-RN-00612-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-08
  • 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-2015-RN-00612-1
  • 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
    Artis system has an x-ray locking function that prevents any accidental release of radiation. if the systems enters "bypass fluoro" mode while the x-ray locking function is active a system error can occur which makes it impossible to exit the locking function without restarting the system or resolving the cause of the "bypass fluoro".In the situation described, no radiation is possible and no fluoroscopic images can be acquired.
  • Acción
    Siemens is developing a software patch to ensure that the Artis system automatically unlocks the radiation release in "Bypass Flouro" mode. This will ensure that imaging is possible in all cases. This action has been closed-out on 22/08/2016.

Device

Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, station...
  • Modelo / Serial
    Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)Catalogue/Lot number – 10094137, 10094135, 10094141, 10094139, 10280959 with software version VC14JARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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