Events

Rappel de Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Beckman Coulter Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20489
  • Date de mise en oeuvre de l'événement
    2016-08-09
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Cause
    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.
  • Action
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • Modèle / numéro de série
    Model: 775222, Affected: , Software version: all software revisions
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc