Events

Hologic Mini C-arm 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Hologic Inc 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
    14588
  • 사례 시작날짜
    2013-06-06
  • 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: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • 원인
    Manufacturer has identified the following compliance issues:, 1.The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate., 2. the total cumulative irradiation time display is not accuarate., both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions., this non-compliance does not pose a health hazard, as the radiation exposure to a patient depends on power settings during the procedure. the system provides the user with accurate dose to the patient information by displaying air kerma and cumulative air kerma.
  • 조치
    Software to be upgraded

Device

Hologic Mini C-arm
  • 모델명 / 제조번호(시리얼번호)
    Model: InSight and InSight 2, Affected:
  • Manufacturer
    Hologic Inc

Manufacturer

Hologic Inc