Events

Rappel de Volcano - Imaging Systems

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Volcano Corporation, Volcarica SRL.

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
    22333
  • Date de mise en oeuvre de l'événement
    2017-11-30
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 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
    Manufacturer to issue advice regarding use

Device

Volcano - Imaging Systems
  • Modèle / numéro de série
    Model: , Affected: Configuration issue that affects some s5i, CORE and CORE Mobile systems with software version v3.5
  • Manufacturer
    Volcano Corporation, Volcarica SRL

Manufacturer

Volcano Corporation, Volcarica SRL
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA