Events

Retiro De Equipo (Recall) de Tumor Localization (TumorLOC) software application used on Philips PET/CT combination diagnostic imaging systems PET/CT system with TumorLOC supplied in Australia: GEMINI TF 64 Slice

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-00627-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-14
  • 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-00627-1
  • 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
    Philips has identified these issue with the tumorloc software1) when a single contour is saved in edit mode, tumorloc does not save the contour in the correct location. the contour is saved in the location of the same slice where the last contour was drawn for the last region of interest (roi) in the roi list. a misplaced contour then results in a misplaced isocenter or incorrect field size. 2) when the region of interest (roi) is displayed on the beam’s eye viewer (bev) in outline mode, and the roi colour is changed, the colour is changed in the multi-planar projection (mpr) viewers but not the bev viewers. 3) tumor loc-created datasets are flipped and incorrectly labelled when non-gated data is loaded along with pulmonary gated data and is used to create intensity projection datasets (mip, minip, or avgip).4) duplicate roi or isocenter names can be created in tumor loc. this duplication is only possible when using the copy feature or manually naming a roi with the suffix copy.
  • Acción
    A Philips Field Service Engineer will implement the Tumor LOC software upgrade to the affected system. In the interim, users are advised to implement workarounds to prevent the failure mode from occurring. This action has been closed-out on 15/08/2016.

Device

Tumor Localization (TumorLOC) software application used on Philips PET/CT combination diagnostic ...
  • Modelo / Serial
    Tumor Localization (TumorLOC) software application used on Philips PET/CT combination diagnostic imaging systems PET/CT system with TumorLOC supplied in Australia: GEMINI TF 64 SliceARTG Number: 118077
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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