Events

Retiro De Equipo (Recall) de Ysio Systems with fixed detector in the wall stand, software version VC10 (Diagnostic 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 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-00956-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-05
  • 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-2014-RN-00956-1
  • 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 received several reports from customers that in case of ysio with fixed detector in the wall stand, an unlikely error may occur, resulting in line artifacts in the image. should these artifacts appear in the region of interest, the examination may need to be repeated.
  • Acción
    Siemens service engineer will contact affected customers to organise and implement a hardware upgrade which will resolve the issue. This action has been closed-out on 06/06/2016.

Device

Ysio Systems with fixed detector in the wall stand, software version VC10 (Diagnostic digital x-r...
  • Modelo / Serial
    Ysio Systems with fixed detector in the wall stand, software version VC10 (Diagnostic digital x-ray system)Catalogue Numbers: 10281013, 10281163 ARTG number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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