Events

KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My Mobility Walking Frame with Front Wheels and Star Glides, Large, Aluminium, APO Grey 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 K Care 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-00277-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00277-1
  • 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
    K care received complaint that the new walking frame has fallen apart while been used by a patient. on examination, 14 walking frames were found to be faulty. k care decided to remove all frames with a white expander connection, as it was apparent they were a different product from the frames that were from earlier deliveries, with a grey expander connector.The material composition of the pintel that connected the horizontal rail to the vertical leg had been changed. the new composition material (white) was too soft and did not retain its integrity when the nut was tightened.
  • 조치
    K Care sales representatives contacted all the customers. All the affected products are corrected. K Care sales representatives also checked the potentially affected products of the model supplied and confirmed that the products are not affected.

Device

KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My...
  • 모델명 / 제조번호(시리얼번호)
    KA351 - My Mobility Walking Frame with Front Wheels, Large, Aluminium, APO Grey, and KA351SG - My Mobility Walking Frame with Front Wheels and Star Glides, Large, Aluminium, APO GreyModel Numbers:KA351 & KA351SGARTG Number: 209821
  • Manufacturer
    K Care Pty Ltd

Manufacturer

K Care Pty Ltd
  • Source
    DHTGA