Events

Rappel de EES Generator 36273

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 Ethicon Endo-Surgery 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
    22695
  • Date de mise en oeuvre de l'événement
    2018-03-06
  • 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 has confirmed a cybersecurity software vulnerability on ethicon generators gen11 and is issuing a field cybersecurity routine update and patch to address that cybersecurity software vulnerability. this cybersecurity software vulnerability can exist when using the gen11 system with non- ethicon disposable devices as it is possible for these devices to bypass the gen11 security authentication., after the update of the gen11 to address the cybersecurity software vulnerability, non-ethicon manufactured products may no longer work on the gen11.
  • Action
    Software to be upgraded

Device

EES Generator 36273

Manufacturer

Ethicon Endo-Surgery Inc