Events

Rappel de EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow analysis)

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-2013-RN-01011-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-25
  • 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-2013-RN-01011-1
  • 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
    A problem has been detected with philips model epiq 7 ultrasound system v1.0 when using philips qlab a2dq software feature. it is possible to have erroneous ejection fraction (ef) measurements appear in the biplane analysis report page under certain conditions while using a2dq. the biplane analysis report page could display ap2 or ap4 edv/esv/ef measurements from a prior patient’s exam. erroneous measurement information in the biplane analysis report page could mistakenly influence patient care. this issue only occurs on software version 1.0 in a2dq during a live (frozen) image and only when a single biplane view is included in the exam. when both biplane views are present (ap2 and ap4) this issue does not occur.
  • Action
    Philips corrected this issue in Version 1.01 of the EPIQ 7 Ultrasound System. A Philips Field Service Engineer will be contacting customers to schedule the V1.01 upgrade to affected systems. Philips is providing temporary workaround instructions to prevent the failure mode from occurring until the systems are upgraded.

Device

EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow an...
  • Modèle / numéro de série
    EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow analysis)ARTG Number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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