Events

Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infant radiant warmer) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia Pty 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
    RC-2012-RN-01081-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-10-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01081-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Ge healthcare has recently become aware of a potential safety issue wherein the oxygen and air wall inlet fittings and/or labels on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate.
  • 조치
    If the affected unit is in use with a patient, GE is asking customers to disconnect the wall supply gas and switch to tank supply. If the affected unit is not currently in use, GE is asking customers to take the unit out of service. A GE Field Engineer will be deployed to the affected site to complete the required repair.

Device

Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infan...

Manufacturer

GE Healthcare Australia Pty Ltd