Events

GE CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 GE Healthcare Finland Oy 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
    16980
  • 사례 시작날짜
    2014-07-11
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • 원인
    Displayed et-/fi o2 values may be incorrect. a random deviation from the allowed tolerance limits of an o2 sensor component in the carescape respiratory modules, the airway gas option and their respective service exchange units could cause up to 50% measurement error in et-/fi o2 values. an incorrect et- /fi o2 value could lead to a potential hypoxic situation or impaired clinical decision making.
  • 조치
    Product to be modified

Device

GE CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE
  • 모델명 / 제조번호(시리얼번호)
    Model: Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE, Affected:
  • Manufacturer
    GE Healthcare Finland Oy

Manufacturer

GE Healthcare Finland Oy