Events

Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Permobil Australia 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-01185-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01185-1
  • 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
    Permobil has been advised of a potential failure of the top plate in which the seating system separates from its base. the top plate is a component that connects the seating system of the wheelchair to the base by a series of welds. the consequences of a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. out of 71 cases reported to the us fda, 3 serious injuries occurred (2 broken bones and 1 laceration).
  • 조치
    Permobil will contact the end users to arrange for service repair kit to be delivered and perform the repair as a permanent correction. For further information, please see https://www.tga.gov.au/product-recall/permobil-powered-wheelchairs-corpus-ii-seating-system

Device

Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)
  • 모델명 / 제조번호(시리얼번호)
    Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)Model: C300 Corpus IISerial Numbers: 2537002437, 2537002471, 2537002476, 2537002514, 2537002746, 2537002891 and 2537002956Model: C350 Corpus IISerial Number: 43203511Model: C500 Corpus IISerial Number: 15702655 Model: C500 Corpus II LRSerial Numbers: 2557000160 and 2557000185ARTG Number: 224603
  • Manufacturer
    Permobil Australia

Manufacturer

Permobil Australia