Events

Rappel de VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS 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
    86178
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-11-17
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Philips volcano is initiating a voluntary correction to address a configuration issue that affects some s5i and core mobile systems with software version v3.5 ("impacted systems"). on certain impacted systems an unexpected microsoft windows security dialog may appear during use and the user's response to the dialog may adversely affect the subsequent operation of the device. 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 is connected. unexpected communication from the hospital network could include normal network security operations e.G. port scanning. if these communications occur during an active ffr/ifr procedure data recording could be affected leading to: -incorrect ffr/ifr measurements -case delay during troubleshooting and/or port scanning -abandonment of use of the system based on our investigation there is only a remote probability that any of these impacts may occur. (see s64 for french translation).

Device

VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT
  • Modèle / numéro de série
    Model Catalog: 400-0100.01 (Lot serial: ALL); Model Catalog: 807400-001 (Lot serial: ALL)
  • Description du dispositif
    VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT;S5I IMAGING SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC