Events

Retiro De Equipo (Recall) de Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10E

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-00626-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-14
  • 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-2015-RN-00626-1
  • 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
    If a position sensor fault in the swivel base axis is not detected by the system software, the c-arm system may 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. there have been no complaints from australian customers regarding this issue.
  • Acción
    This issue will be remedied with software update AX037 /15/S (Patch 2). Following the installation of this update, the speed of the C-arm will be limited to a pre-determined level. This action has been closed-out on 12/08/2016.

Device

Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10E
  • Modelo / Serial
    Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10ECatalogue/Lot number – 10848280, 10848355, 10848282 with SW version VD10EARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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