Events

Siemens MRI system 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Shenzhen Magnetic Resonance 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
    19605
  • 사례 시작날짜
    2015-12-23
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • 원인
    The manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
  • 조치
    Product to be modified

Device

Siemens MRI system

Manufacturer

Siemens Shenzhen Magnetic Resonance Ltd