Events

Rappel de EPIQ 7 V1.0.x/1.1.x with QLAB a2DQ and/or aCMQ plug-ins

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-01254-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-27
  • 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-01254-1
  • 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
    When using the epiq 7 ultrasound system auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller esv calculated by manual tracing without the use of epiq 7 ultrasound system.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 epiq 7 ultrasound system. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.
  • Action
    Philips is providing instructions to assist end users to determine if they are affected by this issue. Philips has developed a software update to correct the issue. A CD with the new version of the software will be sent to all end users for installation. Until the software has been upgraded, the issue can be avoided by ensuring that left ventricular volumes and ejection fraction are calculated by using either the on-cart manual analysis package or off-cart manual analysis package for your primary assessment. This action has been closed-out on 05/08/2016.

Device

EPIQ 7 V1.0.x/1.1.x with QLAB a2DQ and/or aCMQ plug-ins

Manufacturer

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