Events

Retiro De Equipo (Recall) de Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital 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 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-00228-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-14
  • 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-00228-1
  • 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 an issue with the current operating instructions. an existing system function is not fully described in the operating instructions, and this function may allow users to complete a treatment or diagnosis despite a defective focus.For artis systems with the specified software versions, a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear in the foci "small" and "micro" (if present), this performs an automatic focus switch when the footswitch is pressed several times. this special system function is not fully described in the operating instructions currently available. if a focus (small/micro) develops a defect, an alternative focus can be selected by pressing the footswitch several times. this enables radiation to be generated once again so that the clinical treatment or diagnosis can be continued.
  • Acción
    Siemens is providing supplement to the operating instructions that describes the corresponding "system messages" for the existing system function and explains how to use the function properly in the event of a fault. This action has been closed-out on 01/03/2018.

Device

Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic di...
  • Modelo / Serial
    Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital x-ray system)Catalogue Numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848355 ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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