Events

Retiro De Equipo (Recall) de Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis 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 Beckman Coulter 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
    20489
  • Fecha de inicio del evento
    2016-08-09
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Causa
    Manufacturer has received and confirmed a report of a fire within the stainer module of a customer's dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module's methanol bath. beckman coulter is initiating this corective action to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire.
  • Acción
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • Modelo / Serial
    Model: 775222, Affected: , Software version: all software revisions
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc