Events

Rappel de APS EVOTECH Integrated Endoscope Disinfection 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 Advanced Sterilization Products.

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
    15928
  • Date de mise en oeuvre de l'événement
    2013-12-20
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Cause
    The manufacturer of evotech® endoscope cleaner and reprocessors (ecr) has discovered that the evotech® ecr may cancel cycles when reprocessing the pentax eg-3670urk flexible endoscope. the pentax eg-3670urk flexible endoscope has been qualified for use with the evotech® ecr, however it cannot currently be processed in the evotech® ecr due to incorrect flow rate parameter programming in the system that is specific to this endoscope. the minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of low flow.
  • Action
    Software to be upgraded

Device

APS EVOTECH Integrated Endoscope Disinfection System

Manufacturer

Advanced Sterilization Products