Events

Retiro De Equipo (Recall) de Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therapy Treatment Planning System)Elekta Monaco rel. 3.10.00 through 3.20.00

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Elekta 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-2012-RN-00670-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-05
  • 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-2012-RN-00670-3
  • 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 dicom coordinates option is turned on in the reports pull down menu the following issues are seen on the resulting print out:issue 1: the coordinates will be in dicom space, thus not matching the setup reference dialogue.Issue 2: the shift coordinates are reported incorrectly. the z coordinate should become dicom negative y and the y coordinate should become dicom z.Incorrect shift coordinates are generated based on issue 2 above. these shifts can lead to incorrect patient positioning prior to treatment position verification.
  • Acción
    Customers to implement the work around instructions provided by the sponsor until the problem is resolved with the future release of a software patch. This action has been closed-out on 12/02/2016.

Device

Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therap...
  • Modelo / Serial
    Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therapy Treatment Planning System)Elekta Monaco rel. 3.10.00 through 3.20.00ARTG Number: 186856Focal rel. 4.64.00 through 4.70.00ARTG Number: 186853
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DHTGA