Events

Recall of Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SP

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-2013-RN-00555-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00555-1
  • 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 stated tolerance in the instructions for use manual for the recorded scanner output (ctdivol) that is used to approximate patient dose does not accurately represent all systems. on some systems, the measured ctdivol value may fall outside of these stated tolerances. in a worst case scenario, there is the potential for the delivered dose to exceed the reported dose by an amount almost equivalent of a rescan.
  • Action
    Philips is providing their customers with additional information that clarifies published specifications and correlation of CTDIvol value measurement.

Device

Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 1...
  • Model / Serial
    Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SPMultiple product codes affectedARTG Number: 98868Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore Multiple product codes affectedARTG Number: 118077Precedence SPECT/CTMultiple product codes affectedARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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