Events

Retiro De Equipo (Recall) de 550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators

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-00157-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-12
  • 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-00157-1
  • 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
    It has come to siemens attention that it is possible for patients or operators to have their fingers trapped and pinched between the table top and the bottom frame of the 550 txt treatment table.Secondly the manufacturer has received a report on an incident in which a cable inside the 550 txt treatment table has been damaged due to contacting a moving part. this resulted in a short circuit which overheated an electronic circuit board inside the table base.
  • Acción
    Siemens is advising users that the affected treatment tables will be modified to increase the gap between the table top and the base frame to more than 25mm to prevent fingers being trapped or pinched. Siemens will also be modifying the cable routing inside the patient table base in order to ensure the affected cable cannot contact moving parts.

Device

550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
  • Modelo / Serial
    550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear AcceleratorsCatalogue number: 7346534ARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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