Events

Recall of Ingenuity TF PET/CT System with software version 4.0.3.26129

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-2017-RN-01314-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01314-1
  • 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
    Philips is advising of an issue with the qc baseline test. during the pet daily quality control (qc) baseline test, customers may see a popup message on the console stating “communications error. do you wish to continue?”, with the options of “ok” or “cancel”. answering either way may cause the daily qc to fail. in some cases, once this message appears, it will re-appear each time the daily qc is run.
  • Action
    Where Daily QC is unable to be run due to a continual Communication Error, Philips is advising customers to contact their Philips Service Representative to resolve the issue. Philips will correct the issue in an upcoming software release.

Device

Ingenuity TF PET/CT System with software version 4.0.3.26129

Manufacturer

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