Events

Recall of Philips Ultrasound Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps

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-2014-RN-01255-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01255-1
  • 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
    When using the q-station 3.0 auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller esv calculated by manual tracing without the use of q-station 3.0. correspondingly, the left ventricular ejection fraction (ef) calculated using these applications may be higher than the ef calculated by manual tracing without the use of q-station 3.0. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.
  • Action
    Philips is providing instructions to assist end users to determine if they are affected by this issue. Philips has developed a software update to correct the issue. A CD with the new version of the software will be sent to all end users for installation. Until the software has been upgraded, the issue can be avoided by ensuring that left ventricular volumes and ejection fraction are calculated by using either the on-cart manual analysis package or off-cart manual analysis package for your primary assessment. This action has been closed-out on 5/08/2016.

Device

Philips Ultrasound Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps

Manufacturer

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