Events

ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099 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-2017-RN-00786-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-06-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00786-1
  • 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
    Arjohuntleigh has identified that in some instances specific acs900 pumps will constantly deliver pressure to the garment without triggering the alarm. an investigation has concluded that the consistent flow of pressure to the garment without deflation may lead to a potential risk of injury to patients. arjohuntleigh has received a limited number of complaints regarding this specific state.
  • 조치
    ArjoHuntleigh is requesting that customers: 1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this recall for product correction and that all listed devices at their facility are available to be upgraded during the service technician visit; 2. Complete, sign and return the Customer Response Form to ArjoHuntleigh. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices, free of charge.

Device

ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured betwee...
  • 모델명 / 제조번호(시리얼번호)
    ArjoHuntleigh Flowtron ACS900 Active Compression SystemFlowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099Serial Number range: 1400028031 to 1600048470ARTG Number: 254916
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd