Events

Karma Wheelchairs Item Name: Flexx(KM-8022)18*18 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Independent Home Care & Surgical Supplies 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-2015-RN-01157-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01157-1
  • 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
    Incorrect parts were supplied for karma wheelchairs. the bore diameter of the flexx side frame and front caster mount should be y8 to fit m8 screws. however, the flexx that was provided was y6 on the side frame and y8 on the caster mount. the production line did not realise the problem during production and assembled the caster mount to side frame by m6 screws. since the castor mount has bigger holes (y8), the wheelchair is likely to be wobbly while driving and more seriously, after a few months the m6 screws may fall off from the frame.This action was taken prior to consultation with the tga.
  • 조치
    Independent Home Care & Surgical Supplies is contacting users to correct affected units. This action has been closed-out on 11/11/2016.

Device

Karma Wheelchairs Item Name: Flexx(KM-8022)18*18

Manufacturer

Independent Home Care & Surgical Supplies Pty Ltd
  • Source
    DHTGA