Events

Retiro De Equipo (Recall) de Fujifilm Synapse CV Cardio Software

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 Fujifilm Medical Systems USA Inc.

¿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
    16634
  • Fecha de inicio del evento
    2014-05-20
  • 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: Fujifilm NZ Limited, 2c William Pickering Drive, Albany, Auckland
  • Causa
    The "switch user" feature is an option in windows 7 that allows another user to open a new session with his user account without requiring the previous user to log out of the existing session. it has been discovered that running the same synapse cv client application under more than one windows user account simultaneously may cause outbound hl7 reports with incorrect data to be sent to the emr.
  • Acción
    Instructions for use to be updated

Device

Fujifilm Synapse CV Cardio Software

Manufacturer

Fujifilm Medical Systems USA Inc