Events

Recall of Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perform offline measurement and manipulation of CT images, diagnostic X-ray system)

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-2012-RN-01103-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-10-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01103-1
  • 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
    1. when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately. 2. in the calcium scoring protocol, the protocol is switched to mass score but the protocol name remains agatston.3. spline measurement values do not update when adding control point (cp) and when changing the length of the line. 4. in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct cuv values. 5. loading pet images in the ct viewer (ctv) / quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.
  • Action
    Philips is providing work around instructions for each issue and will be implementing a software update to correct the problem.

Device

Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perfor...
  • Model / Serial
    Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perform offline measurement and manipulation of CT images, diagnostic X-ray system)ARTG Number: 119929
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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