Events

Recall of Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CTSoftware release versions between 4.0.0 and 4.1.2 inclusive

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-00212-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00212-1
  • 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
    It is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image. the following key events must take place for harm to occur:- the patient is placed in a “feet-first” orientation.- an interventional ct procedure is scheduled.- contrary to typical clinical practice, a multi-planar reconstruction (mpr) is used for planning the interventional procedure (this issue only occurs in images produced using mpr).- a check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure).- - the needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location).
  • Action
    Philips is advising their customers to refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation. A software update will be implemented to correct the issue. This action has been closed-out on 4/08/2016.

Device

Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Co...
  • Model / Serial
    Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CTSoftware release versions between 4.0.0 and 4.1.2 inclusiveARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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