Events

Recall of Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5

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-00586-1
  • 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-00586-1
  • 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 & therefore additional radiation doses. there have been no reports of injuries as a result of these issues;- scan length changes with a change in the field of view (fov);- the doseright algorithm calculates a water equivalent diameter that is larger than measured on a cylindrical phantom when an 80 kvp or 120 kvp surview is used. this will result in a mas value for the scan that is higher than suggested when using a 100 kvp or 140 kvp surview. (note: the reported mas and ctdi values are correct for all scans & surviews);- wrong scan time estimation due to incorrect intergration time causes the surview scan near 184mm &135mm may result in unexpected scan start positions; &- there may be a discrepancy between the calculated reconstruction length & the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is also not possible.
  • Action
    Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5

Manufacturer

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