Events

Retiro De Equipo (Recall) de Wireless Footswitch used in conjunction with AXIOM Artis, Artis Zee and Artis Q Systems

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-00544-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-20
  • 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-00544-1
  • 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 the wireless footswitch gets disconnected from the loading station due to an unintentional pull of the plug connection, the plug can become damaged.As a consequence, this could have the implication that the wireless footswitch can no longer be charged. safe removal of the plug connection requires the interlocking mechanism to be loosened.
  • Acción
    The cabling that is currently being used will be replaced for all affected systems that are installed. The new solution has a coupling device that automatically unlocks upon draw. In addition, Siemens will provide an addendum for the operating manual that describes the appropriate handling required by the user.

Device

Wireless Footswitch used in conjunction with AXIOM Artis, Artis Zee and Artis Q Systems
  • Modelo / Serial
    Wireless Footswitch used in conjunction with AXIOM Artis, Artis Zee and Artis Q SystemsCharging stations (catalogue no. 04787763) with serial numbers <10,000 are affectedARTG Number: 145549
  • Manufacturer
    Siemens Ltd

Manufacturer

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