Events

Recall of Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary phase issue)

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-2017-RN-00370-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00370-1
  • 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
    An issue has been identified where a retrospective respiratory gated 4d ct scan is performed with the bellows pulmonary gating device, the ct images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%). this may lead to a couple of scenarios that may result in misrepresentation of the 4d ct images with a respiratory gated 4d ct scan and reconstruction. in the event this occurs a misrepresentation of ct images may result, due to the incorrect image pulmonary phase annotation or the need to rescan the patient due to an incorrect image pulmonary phase.
  • Action
    Philips is recommending users to follow the instructions as outlined in the recall notification letter. The letter contains information to prevent the occurrence of the scenarios as well as the corrective actions to take when they do occur.

Device

Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary ph...
  • Model / Serial
    Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary phase issue)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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