Events

Recall of 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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00627-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00627-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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 ...
  • Model / 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
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA