Miele washer-disinfectors when connected to an in-house network 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Miele Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00587-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-16
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    Miele have identified an it security vulnerability affecting specific models of miele washer-disinfectors. these washer-disinfectors feature a network interface for connection to an in-house network for cycle documentation purposes. 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. to date, there has been no evidence indicating that such an incident has ever occurred.
  • 조치
    Miele is working on a solution for this issue. In the interim, Miele is recommending users implement the following measures in order to minimise risks: 1. Ensure that all relevant staff members using the machine are informed of this product correction; 2. Do not enable access to the machine via the Internet (e.g. through port forwarding). If the machine is accessible via the Internet, deactivate any Internet connections immediately; 3. Only operate these machines in a separate section of the network (physically separated or protected by access authorisation systems by configuring routers/firewalls). In this network, only operate the systems required for the documentation of reprocessing results (e.g. PC and printer);and 4. Access to any affected machine and access-authorised systems should be limited exclusively to persons requiring access. 4.1 Access-authorised systems should be protected using strong passwords. 4.2 Alter existing passwords on machines (cf. programming manual).

Device

  • 모델명 / 제조번호(시리얼번호)
    Miele washer-disinfectors when connected to an in-house networkModel Numbers: PG 8527, PG 8528, PG 8535 and PG 8536ARTG Number: 280003
  • Manufacturer

Manufacturer