Events

Recall of Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used with associated Pinnacle3 Tumor LOC server (version 14.0)

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-2018-RN-00085-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00085-1
  • 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 became aware of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are:1- efov (extended field of view) check message does not display when fov is set >600mm for a paused scan2- prefer “center x/y 0” and “disable result rotation” checkboxes checked automatically when checking the "ct simulation"3- tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed4- tracker scan completed, no images were generated5- continuous link plans the clinical scan outside the surview6- applying tilt on first mpr result, when the other axial results are unplanned causes change in scan length and number of cycles of scan7- “system is still initializing. please wait…” error8- auto locations not functioning as expected9- system ended exam before completion10- system freeze-up after pause is pressed.
  • Action
    Philips is releasing a Field Change Order (FCO) to correct these issues. A Philips Field Service Engineer will contact users to schedule the FCO updates. In the interim, users are advised to refer to the Customer Letter for respective actions in regards to the outlined issues.

Device

Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used...
  • Model / Serial
    Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used with associated Pinnacle3 Tumor LOC server (version 14.0)ARTG Number: 98868 (Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body)
  • Product Classification
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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