Events

Recall of EES Generator 36273

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ethicon Endo-Surgery Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    22695
  • Event Initiated Date
    2018-03-06
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    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