Events

Retiro De Equipo (Recall) de HS Hospital Service SpA Amica Dual Ablation System

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 HS Hospital Service SpA.

¿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
    21332
  • Fecha de inicio del evento
    2017-04-18
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    A manufacturer's internal audit has discovered that a power supply unit that was installed in the generators above was not in compliance with the ce certification. due to this, the ce certification has been withdrawn from specific serial numbers only., the manufacturer has advised that electrical safety tests performed on these generators have passed and the reports are valid, and see no potential risk for patients or users.
  • Acción
    Product to be returned to supplier

Device

HS Hospital Service SpA Amica Dual Ablation System

Manufacturer

HS Hospital Service SpA