Events

Recall of Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning)

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-2016-RN-00576-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00576-1
  • 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 following issues have been identified which may result in additional patient scanning and threfore additional radiation doses. there have been no reports of injuries as a result of these issues;- sagittal result shortened for axial head scans.- when axial images are acquired with a gantry tilt, the scan increment is manually changed to the same value as the collimation, the console viewer will not allow creation of mpr images due to the scan series being broken into serval series of images.- scan length changes with a change in field of view (fov).- scan length changes on subsequent axial results.- surview scan lengths near 184.4mm & 135.0mm may result in unexpected scan start positions.- there may be a discrepancy between the calculated reconstruction length and the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is not possible.
  • Action
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity...
  • Model / Serial
    Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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