Events

Retiro De Equipo (Recall) de Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CTSoftware release versions between 4.0.0 and 4.1.2 inclusive

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-2015-RN-00212-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-13
  • 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-2015-RN-00212-1
  • 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 is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image. the following key events must take place for harm to occur:- the patient is placed in a “feet-first” orientation.- an interventional ct procedure is scheduled.- contrary to typical clinical practice, a multi-planar reconstruction (mpr) is used for planning the interventional procedure (this issue only occurs in images produced using mpr).- a check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure).- - the needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location).
  • Acción
    Philips is advising their customers to refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation. A software update will be implemented to correct the issue. This action has been closed-out on 4/08/2016.

Device

Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Co...
  • Modelo / Serial
    Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CTSoftware release versions between 4.0.0 and 4.1.2 inclusiveARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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