Events

Recall of Philips EPIQ 7 Ultrasound 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-2014-RN-00359-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00359-1
  • 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
    The epiq 7 will report incorrect doppler velocities if users use high pulse repetition frequency (hprf) with multiple sample volume gates.While in high pulse repetition frequency (hprf) in ‘display zoom velocity scale’ using manual spectral doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. the erroneous values are reported on the reports page and in dicom sr if exported and include the following velocities and calculations:general imaging, (gi)-- peak systolic velocity (psv)- end diastolic volume (edv)- minimum diastolic velocity (mdv)- time averaged peak velocity (tapv)- time averaged mean velocity (tamv)affected gi calculations:- s/d (ratio of peak systolic velocity / peak diastolic velocity)- resistivity index (ri)- pulsatility index (pi).
  • Action
    Philips has corrected the issues in version 1.1.2. Philips is advising their customers to not use HPRF in doppler mode until the affected system is upgraded to version 1.1.2. This action has been closed-out on 18/02/2016.

Device

Philips EPIQ 7 Ultrasound System

Manufacturer

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