Events

Retiro De Equipo (Recall) de Miele PG 8535 Washer-disinfector

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 Miele & Cie KG.

¿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
    21342
  • Fecha de inicio del evento
    2017-04-24
  • 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: Miele NZ Ltd, Level 2, 10 College Hill, Freemands Bay, Auckland 1011
  • Causa
    An it security vulnerability was discovered in a network penetration test carried out by an it security expert. this only applies to machines which are actually connected to an in-house network. the machines affected feature so-called pst 10 controls. this set of controls is used on pg 8535, pg 8536, pg 8527 and pg 8528 washer-disinfectors., in the event of an attack on the internal network of a hospital, a laboratory or a surgery, there is a risk that (mostly encoded) data can be read out from the affected miele washer-disinfectors.
  • Acción
    Manufacturer to issue advice regarding use

Device

Miele PG 8535 Washer-disinfector
  • Modelo / Serial
    Model: , Affected: Miele PG 8527, PG 8528, PG 8535, PG 8536 washer-disinfectors
  • Manufacturer
    Miele & Cie KG

Manufacturer

Miele & Cie KG