Events

Retiro De Equipo (Recall) de Sorin (Cellplex) Heater Cooler

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 Cellplex Pty Ltd.

¿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
    21416
  • Fecha de inicio del evento
    2017-05-15
  • 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
    Manufacturer has completed the development of and obtained ce mark for a solution that mitigates against contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. this solution will be implemented in manufacturing, and units currently in use in the field will undergo an upgrade on-site by the obex field service engineer. although this solution is less necessary when the 3t device's water system is maintained according to the ifu, the field upgrade will mitigate against the reasonably foreseeable hazard of accidental contamination and poor maintenance practices.
  • Acción
    Product to be modified

Device

Sorin (Cellplex) Heater Cooler

Manufacturer

Cellplex Pty Ltd