Events

Notificaciones De Seguridad De Campo acerca de Volcano 55, sSi, CORE and CORE Mobile

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Philips.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-05-06
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Volcano is launching a voluntary remedial action on its own, because one problem has arisen with the v3.2.X, v3.3 and v3.4 software versions running on 55 / ssi / core / core mobile systems ("affected systems") . the withdrawal covers only the affected systems. volcano was aware of the incompatibility between the affected systems and the hospital network scan. in special circumstances b0 the affected system encounters unexpected data from the i2 hospital network for which the system will have to be restarted manually. this condition can occur at any time, even in the middle procedure on the patient.

Device

Volcano 55, sSi, CORE and CORE Mobile
  • Modelo / Serial
  • Manufacturer
    Philips

Manufacturer

Philips
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    AMPMDRS