Events

Miele PG 8528 Washer-disinfector 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Miele & Cie KG 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
    21342
  • 사례 시작날짜
    2017-04-24
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Recalling Organisation: Miele NZ Ltd, Level 2, 10 College Hill, Freemands Bay, Auckland 1011
  • 원인
    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.
  • 조치
    Manufacturer to issue advice regarding use

Device

Miele PG 8528 Washer-disinfector
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Miele PG 8527, PG 8528, PG 8535, PG 8536 washer-disinfectors
  • Manufacturer
    Miele & Cie KG

Manufacturer

Miele & Cie KG