Events

Aegis Standing Sling - Lift, patient transfer, sling/harness/strap 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Solari Medical 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-2015-RN-00308-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00308-1
  • 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
    During the use of the device it was noticed by the healthcare professional that the stitching on one of the loops holding the sling to the spreader bar of the hoist had come loose. no harm came to the patient or the healthcare worker. the stitching had become loose after more than twelve months use due to either wear or inadequate back stitching and could have been exacerbated if the operator had incorrectly twisted the loop when attaching it to the spreader bar.
  • 조치
    Solaris Medical is contact end users through the distributors to advise of the potential issue. Solaris Medical will inspect all potentially affected units and repair if damaged. This action has been closed-out on 15/08/2016.

Device

Aegis Standing Sling - Lift, patient transfer, sling/harness/strap
  • 모델명 / 제조번호(시리얼번호)
    Aegis Standing Sling - Lift, patient transfer, sling/harness/strapARTG Number: 203097
  • Manufacturer
    Solari Medical

Manufacturer

Solari Medical
  • Source
    DHTGA