Events

Retiro De Equipo (Recall) de Volcano - Imaging Systems

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Volcano Corporation, Volcarica SRL.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    22333
  • Fecha de inicio del evento
    2017-11-30
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    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.
  • Acción
    Manufacturer to issue advice regarding use

Device

Volcano - Imaging Systems
  • Modelo / Serial
    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
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA