Events

Retiro De Equipo (Recall) de Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC21B(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-2015-RN-00483-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-05
  • 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-00483-1
  • 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
    A possible position sensor fault in the swivel base axis not being detected by the system software may cause the c-arm system to move faster than normal when movement is enabled by the operator. the system will not move of its own accord, movement must still be initiated by the operator, however the system can unexpectedly exceed its usual speed, potentially resulting in a collision.
  • Acción
    This issue will be remedied with software update (Patch 12). Following the installation of this update, the possible speed of the Artis system will be limited to the permissible level. This action has been closed-out on 19/08/2016.

Device

Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW ve...
  • Modelo / Serial
    Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC21B(fluoroscopic angiographic x-ray system)Catalogue numbers: 10094135, 10094141, 10094139 ARTG Number - 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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