Events

Oxford Dipper Hoist 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Sunrise Medical 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-01233-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01233-1
  • 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
    The manufacturer joerns healthcare has revised the service life statement and related manufacture guidance for the oxford dipper hoist. it is possible that issues such as corrosion can occur rapidly in units older than 7 years and this may not be externally visible to users. joerns healthcare strongly recommends load testing for the oxford dipper is carried out at each and every 6 monthly inspection due to the hostile environment in which it resides and operates. the humid and corrosive nature of the pool-side locations can potentially lead to product deficiencies that may otherwise remain undetected.
  • 조치
    Load testing for the Oxford Dipper should be carried out at every six-monthly inspection The Oxford Dippers that are older than 7 years need to be changed out prior to the following scheduled (6 monthly) inspection to ensure the ongoing safety of users. Recipients are requested to contact all customer(s) supplied with the supplied serial numbers, then complete the supplied Receipt Form with the appropriate box checked, according to disposition of each hoist as soon as the information becomes available or the change out is complete.

Device

Oxford Dipper Hoist
  • 모델명 / 제조번호(시리얼번호)
    Oxford Dipper Hoist Models: OP10013, OP10014, X10013 and X10014Purchased between 2001 and 2010Multiple Serial Numbers affectedARTG Number: 101030
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd