Events

Rappel de Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software

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-2015-RN-00335-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-20
  • 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-2015-RN-00335-1
  • 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 qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller than the esv calculated by manual tracing without the use of qlab. 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 qlab. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.An incorrect ejection fraction calculation could lead to misdiagnosis and/or delayed or incorrect therapy if healthcare providers make clinical decisions based solely on these measurements, without considering other available clinical data.
  • Action
    Philips is providing temporary work instructions for users to follow until a software upgrade to QLAB Version 10.2 or higher is completed. This action has been closed-out on 12/08/2016.

Device

Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcele...
  • Modèle / numéro de série
    Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera softwareARTG number: 170658
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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