Events

Recall of Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex. Software versions V3.6.1, V3.6.2, V3.6.4, and V3.6.5 (X-ray system, diagnostic, computed tomography, full-body)

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-00987-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00987-1
  • 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
    Image position accuracy - image rotation calibration program performed by field service engineer can report pass but fail to produce the correct angular rotation offset value for the ultra-fast scan mode. the inaccurate angular rotation offset can impact the accuracy of radiation treatment planning.Tracker image artefact - tracker scan image of ct angiography (cta) examination can exhibit a streaking artefact. due to the streaking artefact, the automatic clinical scan may be triggered at the wrong time resulting in suboptimal ct diagnostic images that do not capture the bolus peak of the imaged body section.Ring/dot image artefact due to x-ray measurement - after a complete system power shutdown and power up, if a head scan is performed without air calibration and without quick iq check scan after power up, intermittent ring/dot image artifacts in the reconstructed images may occur.
  • Action
    Philips Healthcare are providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent correction. This action has been closed-out on 31/08/2016.

Device

Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brillian...
  • Model / Serial
    Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex. Software versions V3.6.1, V3.6.2, V3.6.4, and V3.6.5 (X-ray system, diagnostic, computed tomography, full-body)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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