Events

Recall of TumorLOC (intensity projection dataset software) use with: Brilliance CT Big Bore, EBW, GEMINI LXL, GEMINI TF 16, GEMINI TF 64 & GEMINI TF Big Bore (radiology systems)

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-2012-RN-01223-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01223-1
  • 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
    The tumorloc application has the capability to generate intensity projection datasets from respiratory gated data. a circumstance has been identified where these generated datasets are flipped and incorrectly labelled left to right when they are saved to disk.
  • Action
    Work around instructions will be provided to customers to avoid the problem. A software update is under development and will be implemented once complete. This action has been closed-out on 11/04/2016.

Device

TumorLOC (intensity projection dataset software) use with: Brilliance CT Big Bore, EBW, GEMINI LX...
  • Model / Serial
    TumorLOC (intensity projection dataset software) use with: Brilliance CT Big Bore, EBW, GEMINI LXL, GEMINI TF 16, GEMINI TF 64 & GEMINI TF Big Bore (radiology systems)Multiple affected serial numbersARTG Number: 117441
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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