Events

Rappel 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00627-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-14
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00627-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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 ...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA