Events

Siemens AXIOM Artis zee X-ray system, handswitch 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens AG 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
    16855
  • 사례 시작날짜
    2014-06-18
  • 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
    There is a potential problem with axiom artis or artis zee system in connection with hand switch material number 3771750 operated at the patient table to release a x-ray image. the hand switch to release an x-ray image at the patient table is equipped with a cable extension inside the table. a problem may occur if the connection between cable connection and hand switch is contaminated with an extraordinary large amount of fluid. in a worst case situation, uncontrolled release of an x-ray image may happen. if this situation occurs, the system terminates uncontrolled x-ray after a short period.
  • 조치
    Product to be modified

Device

Siemens AXIOM Artis zee X-ray system, handswitch
  • 모델명 / 제조번호(시리얼번호)
    Model: Model: 3771750, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG