Retiro De Equipo (Recall) de Natus Medical EEG Machines using Neuroworks v8.5 software

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare Pty Ltd.

¿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
    RC-2018-RN-00575-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-27
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    There have been multiple vulnerabilities discovered in natus neuroworks software, which is used in natus xtek eeg medical products. the vulnerable devices contain an ethernet connection for data acquisition and connection to networks. under certain scenarios, these vulnerabilities allow a remote attacker to run arbitrary code on the device, including a denial of service attack.
  • Acción
    Life Healthcare is advising that this issue is resolved in an updated software version - Neuroworks 8.5 GMA2. This software will be installed for users by Life Heathcare either on-site or via remote access depending on system setup.

Device

  • Modelo / Serial
    Natus Medical EEG Machines using Neuroworks v8.5 softwareARTG Number: 197550(Life Healthcare Pty Ltd - Electroencephalograph)
  • Manufacturer

Manufacturer