Events

Rappel de Philips EPIQ 5 Ultrasound System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00360-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-25
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00360-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    The epiq 5 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 software 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 12/02/2016.

Device

Philips EPIQ 5 Ultrasound System

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA