Events

Retiro De Equipo (Recall) de Artis systems used in conjunction with Artis table

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-00677-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-28
  • 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-00677-1
  • 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
    For artis systems used in conjunction with artis table;- in the event the tabletop is approximately fully extended at the head end and there is a large amount of liquid on the table surface, the liquid may make its way from the foot end of the tabletop onto the top cover of the table column where it can seep through a gap. this liquid may then cause interference with electronic components and table movements may no longer be possible.
  • Acción
    The gap in the top of the table cover will be sealed to ensure protection against the entry of liquids.

Device

Artis systems used in conjunction with Artis table
  • Modelo / Serial
    Artis systems used in conjunction with Artis tableCatalogue and Serial number – Multiple serial number ranges of Artis tables with the following Siemens Material Numbers: 5767004 5767012 5767020 5767053 10759275 10759276 10759277 10759278ARTG number – 102173 and 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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