Events

Recall of Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software

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-2015-RN-00335-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00335-1
  • 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 qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller than the esv calculated by manual tracing without the use of qlab. 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 qlab. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.An incorrect ejection fraction calculation could lead to misdiagnosis and/or delayed or incorrect therapy if healthcare providers make clinical decisions based solely on these measurements, without considering other available clinical data.
  • Action
    Philips is providing temporary work instructions for users to follow until a software upgrade to QLAB Version 10.2 or higher is completed. This action has been closed-out on 12/08/2016.

Device

Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcele...
  • Model / Serial
    Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera softwareARTG number: 170658
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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