Events

Recall of Ultrasound Q-Station version 3.0 or higher

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-00491-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00491-1
  • 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
    If a user opens a study for review on q-station before its transfer from the ultrasound system cart has completed, measurements from that study (structured report) may be appended to subsequent studies for other patients. as a result, measurements from one patient may be presented in another patient’s study, due to a failure to clear previous patient information when selecting the new study.This hazardous situation will exist only if all of the following events occur: a user performs and completes a study (study a) on the ultrasound system that includes sr (structured report) measurements and initiates the export of study a to q-station (‘manual’, ‘auto’ or ‘send as you scan’).The user opens study a for review on q-station using view/report/export before the transfer of the sr is complete. no reports of misdiagnosis or harm as a result of the data mixing have been received.
  • Action
    Philips has corrected this issue via software version 3.3.2 and is sending a CD with this latest version of Q-Station to the affected customer, free of charge. This action has been closed-out on 17/08/2016.

Device

Ultrasound Q-Station version 3.0 or higher

Manufacturer

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