Events

Savion ED Trolley (mobile stretcher) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Huntleigh Healthcare 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-00930-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00930-1
  • 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
    It has been determined that the a number of trolleys with the affected serial numbers have been supplied to arjohuntleigh with the incorrect tbb6 battery. this may result in a burning smell when connected to mains power. there have been no reports of injuries as a result of this issue.
  • 조치
    ArjoHuntleigh has advised users to remove the stretchers from use. The batteries will be replaced by unaffected stock as a permanent correction. This action has been closed-out on 03/08/2016.

Device

Savion ED Trolley (mobile stretcher)
  • 모델명 / 제조번호(시리얼번호)
    Savion ED Trolley (mobile stretcher)Model Number: ES-711XSerial Number: 20150811XXXX, 201508170001 and 201508170002ARTG Number: 225146
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd