Events

Level 1 Fast Flow Fluid Warmers with and without Air Detection 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia 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-2013-RN-00091-2
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-01-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00091-2
  • 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
    A limited number of fluid warmers were manufactured with an incorrect printed circuit board component which could prevent the fluid warmer from functioning as intended and also potentially exhibiting a false over temperature alarm.
  • 조치
    Smiths Medical Australasia is requesting users to identify any affected units and place in quarantine. A Biomedical Technician will inspect devices to determine if they are affected and provide a correction.

Device

Level 1 Fast Flow Fluid Warmers with and without Air Detection
  • 모델명 / 제조번호(시리얼번호)
    Level 1 Fast Flow Fluid Warmers with and without Air Detection Item Code: H-1200Affected Serial Numbers: S103A00028, S103A00029, S103A00094 and S103A00095ARTG Number: 108420
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd