Events

C- Series lifts Manufactured between April 25, 2017 and June 12, 2017 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CHS 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-01450-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01450-1
  • 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 internal cycle testing of c-series lifts handicare has found that the c-series lift strap for lifts manufactured between april 25, 2017 and june 12, 2017 may wear prematurely at max load (625 lbs). we have identified the root cause as a supplied component that was not to specification. if the strap wears during use there is a potential risk for the person being supported by the lift to drop.This issue was identified internally. to date, chs is not aware of any c-series lift strap incidence related to this issue.
  • 조치
    CHS Healthcare will be in contact with affected customers to arrange removal of the current hoist and reinstall of a new unit.

Device

C- Series lifts Manufactured between April 25, 2017 and June 12, 2017
  • 모델명 / 제조번호(시리얼번호)
    C- Series liftsManufactured between April 25, 2017 and June 12, 2017ARTG 292642
  • Manufacturer
    CHS Healthcare Pty Ltd

Manufacturer

CHS Healthcare Pty Ltd