Events

Retiro De Equipo (Recall) de EES Generator 36273

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 Ethicon Endo-Surgery 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
    22695
  • Fecha de inicio del evento
    2018-03-06
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    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.
  • Acción
    Software to be upgraded

Device

EES Generator 36273

Manufacturer

Ethicon Endo-Surgery Inc