Events

Recall of Philips Ultrasound QLAB versions 10.0 and 10.1

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-00837-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00837-1
  • 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 healthcare has discovered a problem in the philips ultrasound qlab version 10.0 and 10.1 when used on a picture archiving and communication system (pacs) or with third party pacs integration that could result in the erroneous calculation of ejection fraction (ef) from the results of a2dq and acmq patient exams. an incorrect ef calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
  • Action
    Philips has corrected this issue in QLAB version 10.2, and is sending a CD with QLAB version 10.2 to affected customers. Until your software can be upgraded to QLAB version 10.2, end users can avoid the issue by: - Ensuring that a2DQ patient exams include both biplane views for AP2 and AP4. When both biplane views are present, EF measurements will not persist from measurements taken in a prior patient exam. - Ensuring that aCMQ patient exams include all three views (AP2, AP3, and AP4). When all three views are present, measurements will not persist from measurements taken in a prior patient exam. This action has been closed-out on 03/06/2016.

Device

Philips Ultrasound QLAB versions 10.0 and 10.1
  • Model / Serial
    Philips Ultrasound QLAB versions 10.0 and 10.1Part Numbers: 453561704771 and 453561728001ARTG Number: 100468
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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