Events

Infant Warmer System (IWS) 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-2016-RN-01189-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01189-1
  • 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 related to loose screws in the “heater head” of certain infant warmer system (iws) devices. hot screws from the “heater head” of the iws could fall onto the bed if the “heater head” assembly has been improperly serviced. this could result in thermal injury to a patient. to date, two injuries have been reported as a result of this issue.
  • 조치
    GE Healthcare is providing users with interim instructions to check the screws on the "Heater Head" are tight. This will form part of the annual Preventative Maintenance check to ensure the screws are tightened. This action has been closed-out on 23/05/2017.

Device

Infant Warmer System (IWS)
  • 모델명 / 제조번호(시리얼번호)
    Infant Warmer System (IWS)Model Numbers: 3000 IWS, 3300 IWS, 3400 IWS and 4400 IWSARTG Number: 139290
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd