Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Otto Bock Australia 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-2014-RN-00458-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-23
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 course of on-going market observations the front caster fork complaint rate of the three wheelchairs has increased. a detailed analysis of the reports shows that the caster forks may, in unusual circumstances, break when repeatedly driven over or against street curbs.
  • 조치
    Ottobock Healthcare is replacing the caster fork on all affected A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs. Product corrections are to be carried out by the wheelchair dealer. For more details, please see http://www.tga.gov.au/safety/alerts-device-ottobock-power-wheelchairs.htm .

Device

  • 모델명 / 제조번호(시리얼번호)
    Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013ARTG Number: 177246
  • Manufacturer

Manufacturer