Notificaciones De Seguridad De Campo acerca de Miele PG 8528/PG 8527/PG 8535/ PG 8536 washer-disinfector

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Miele.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
  • País del evento
  • Fuente del evento
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    The purpose of this correspondence is to bring an it security vulnerability to your attention affecting a machine type in use at your site which was discovered in the course of a penetration test carried out by an it security expert. this only applies to machines which are actually connected to an in- house network. all other machines are not affected and are therefore not at risk. the following applies to machine in a network: • in the event of an attack on the in-house network of a hospital, a laboratory or a surgery, there is a risk that data from miele washer-disinfectors can be read out and/or replaced. this data is for the most part binary code. • theoretically, a hacker with criminal intent could attempt to make abusive use of this data in order to obtain access to the programme controls and to manipulate these. if pursued to the limit, hackers could even, after further data analysis and with a knowledge of instrument reprocessing, try to falsify cycle records with a view to covering up manipulation. the same applies to unauthorised actions on the part of persons with legal access to the appropriate network. • to date, there has been no evidence indicating that such an incident has ever occurred. such targeted manipulation of data, as described above, would require considerable effort and an in-depth knowledge of this highly specific machine software. miele considers the risk of a hacker successfully carrying out the multi-stage manipulation described above and causing a potential threat to the health of patients to be extremely low. .