Events

Retiro De Equipo (Recall) de Artis Q and Artis Q.zen Ceiling Systems (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-01307-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-12
  • 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-01307-1
  • 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
    During regular product monitoring, wear on system cabling was identified. in particular, wear may occur at the cable outlet of the inner c-arm. this problem is not systematic, but occurs sporadically on individual systems throughout the lifetime of the system. suboptimal routing of the cable may result in increasing wear. without intervention to manage this wear, damage to cabling may result in limited functionality and, in the worst case, system failure where a procedure may need to be terminated.
  • Acción
    The existing cable routing at the C-arm will be modified to prevent cable damage. The following hardware modification will be implemented in the field : 1. A modified cable outlet to provide additional space for the cabling. 2. A modified plastic cover at the cable outlet providing optimal cable guidance in the area most at risk of wear All systems will be checked to determine if there is existing damage to cabling. Where damage is observed, the entire cable harness will be replaced. This action has been closed-out on 14/07/2016.

Device

Artis Q and Artis Q.zen Ceiling Systems (Fluoroscopic angiographic x-ray system))
  • Modelo / Serial
    Artis Q and Artis Q.zen Ceiling Systems (Fluoroscopic angiographic x-ray system)) Serial Numbers: 109000 to 109091 (Artis Q), and 111000 to 111005 (Artis Q.zen)ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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