Recall of WASHER-DISINFECTOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MIELE LIMITED.

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
    16701
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-13
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • 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. 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.

Device

  • Model / Serial
    Model Catalog: PG 8527 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: PG 8535 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: PG 8536 (Lot serial: >10 CONTACT MANUFACTURER); Model Catalog: PG 8528 (Lot serial: >10 CONTACT MANUFACTURER)
  • Product Description
    PG 8528/PG 8527/PG 8535/ PG 8536 WASHER-DISINFECTORS
  • Manufacturer

Manufacturer

  • Manufacturer Address
    VAUGHAN
  • Source
    HC