Events

Retiro De Equipo (Recall) de Fujifilm ProSolv (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
    23177
  • Fecha de inicio del evento
    2018-06-22
  • 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 manufacturer has become aware of a malfunction in the system where inconsistent mitral valve mean pressure gradient values are being reported. the values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the synapse cv measurement tools. multiple traces measured on the modality and transmitted to synapse cv are not affected.
  • Acción
    Software to be upgraded

Device

Fujifilm ProSolv (Synapse CV) Cardio Software

Manufacturer

Fujifilm Medical Systems USA Inc