Events

Retiro De Equipo (Recall) de Pinnacle3 Radiation Treatment Planning System, software version 9.0

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-00291-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-11
  • 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-00291-1
  • 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
    When the user changes from one treatment machine to another, the jaw symmetry yes or no option may be set incorrectly to symmetric. when exported via dicom rt, multileaf collimator (mlc) and jaw positions agree with the pinnacle3 plan. however, because the jaw symmetry flag is set to yes, the record and verify (r&v;) system may force the jaws to be symmetric, thereby re-positioning the beam. the resulting beam on the r&v; system does not match the beam in pinnacle3 resulting in an incorrect dose to the target or other structure. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.
  • Acción
    Philips is providing an update to software version 9.2 to all customers who have software version 9.0 installed. Until the update is applied, customers are advised to manually cick the button to set it to No if they observe the jaw symmetry is set to Yes inappropriately.

Device

Pinnacle3 Radiation Treatment Planning System, software version 9.0

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA