Events

Rappel de Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare 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-2016-RN-00602-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-05-10
  • 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-2016-RN-00602-1
  • 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 manufacturer, volcano corporation has become aware of a system incompatibility issue between the affected systems and hospital network scans. in specific circumstances, a system will encounter unexpected data from the hospital network and the system will need to be manually rebooted. this condition can occur any time, including in the middle of a patient procedure.The system incompatibility issue occurs when hospital staff scan their networks for potential security vulnerabilities and the user is required to manually reboot the system. if this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of ivus and ffr/ifr functionality in the procedure. there have been no reports of injuries associated with this issue.
  • Action
    LifeHealthcare is providing users with work around instructions to follow as an interim measure. A correction is being developed as a permanent correction. This action has been closed-out on 24/05/2017.

Device

Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to di...
  • Modèle / numéro de série
    Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction)ARTG Number: 131371
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd