Events

Rappel de Volcano Imaging Systems and Core Mobile Imaging Systems

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-2017-RN-01474-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-12
  • 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-2017-RN-01474-1
  • 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 microsoft windows security settings on a small number of impacted systems were incorrectly configured during the manufacturing process. this misconfiguration can lead to a windows security alert dialog being displayed when the system is switched from ivus to the ffr/ifr mode. if the user responds to the dialog by selecting "allow access," the device's network firewall settings will be modified, opening its network ports to potential unexpected communication from the hospital network to which the device may be connected.
  • Action
    Philips Healthcare is arranging a service technician to visit customers to inspect the system configuration. In the interim, users may follow the workaround instructions provided in the customer letter to bypass changes to the firewall permissions that may impact the system.

Device

Volcano Imaging Systems and Core Mobile Imaging Systems
  • Modèle / numéro de série
    Volcano Imaging Systems and Core Mobile Imaging SystemsPart Numbers, 80740001, 400-0100.01, 400-0100.01-R, 400-0100.07, 400-0100.07-R, 400-0100.08, 400-0100.08R, 400-0100.02With software version v3.5Manufactured between 23 March 2016 to 18 October 2017ARTG Number: 285510
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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