Events

Rappel de Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE Series Software versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical Vision Aust Cardiology & Thoracic Pty 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-00715-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-13
  • 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-00715-1
  • 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
    Volcano corp. has discovered a very specific workflow scenario where the aortic pressure (pa) offset used in the ffr/ifr modalities will be lost or reset to 0 mmhg due to a software error. this issue can lead to an inaccurately calculated ffr or ifr value. should this occur, a clinician may rely on an inaccurate value in diagnosing a patient's condition. if the pa was not zeroed through the volcano system as part of the workflow, this software issue has no impact on the ffr / ifr values or on the patient.
  • Action
    Medical Vision Australia is advising their customers that if zeroing Pa is warranted, as described in the FFR Option Operator's Manual, performance of this product cannot be assured until the software update is provided. A Medical Vision Australia Representative will contact affected hospitals to schedule a correction to the software in the next few weeks. This action has been closed-out on 24/08/2016.

Device

Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE Series Software versions 3.3, 3.4 (wit...
  • Modèle / numéro de série
    Volcano IVUS Ultrasound Imaging System Volcano s5 and CORE SeriesSoftware versions 3.3, 3.4 (with and without iFR Scout technology) and v3.4 software kits
  • Manufacturer
    Medical Vision Aust Cardiology & Thoracic Pty Ltd

Manufacturer

Medical Vision Aust Cardiology & Thoracic Pty Ltd