Events

Recall of Miele PG 8535 Washer-disinfector

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Miele & Cie KG.

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
    21342
  • Event Initiated Date
    2017-04-24
  • 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: Miele NZ Ltd, Level 2, 10 College Hill, Freemands Bay, Auckland 1011
  • Reason
    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.
  • Action
    Manufacturer to issue advice regarding use

Device

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

Manufacturer

Miele & Cie KG