Miele PG 8528/PG 8527/PG 8535/ PG 8536 washer-disinfector 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Miele 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-04-05
  • 사례 국가
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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. .

Device

  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer

Manufacturer