Events

Retiro De Equipo (Recall) de MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codes

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-01358-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-23
  • 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-01358-1
  • 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 reports of one circuit board (g41) located inside of the linac gantry showing signs of overheating. after a detailed analysis the root cause was found to be one of the components that belong to this board (head driver pcb). siemens has redesigned the head driver pcb to further mitigate the risk of local overheating on the g41 motherboard.
  • Acción
    Siemens has redesigned the Head Driver PCB to further mitigate the risk of local overheating on the G41 motherboard. The present corrective action comprises the replacement of the Head Driver PCB by a redesigned component on your LINAC. This action has been closed-out on 12/08/2016.

Device

MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codes
  • Modelo / Serial
    MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codesAll serial numbersARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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