Events

Freedom Healthcare Quad Walkers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Gainsky 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-01130-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01130-1
  • 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 sponsor has become aware of a fault where the front right wheel of specific quad walkers has either worked loose, or the wheel has sheared off the frame of the walker. when the wheel shears off, the wheeler becomes unstable and the user may become unsteady on their feet and lose their balance.
  • 조치
    1. Users are to find the information sticker on the walker and look at the batch number stamped on the sticker. Photographs of the location of the sticker to assist customers will be provided with the customer letter. Verify the unit is affected stock. 2. Take the walker to the place of purchase where you will be offered a replacement walker or a refund of your purchase price. 3. A representative will contact distributors to arrange to recover any stock of the defective products held and replace them with sound items. For further information, please see https://www.tga.gov.au/alert/freedom-healthcare-quad-walkers

Device

Freedom Healthcare Quad Walkers
  • 모델명 / 제조번호(시리얼번호)
    Freedom Healthcare Quad WalkersModel Numbers: BRO209 and BRO199Batch Numbers: FHFHCBR13 and FHFHCBR15Manufactured in June 2016 and October 2016 ARTG Number: 137219
  • Manufacturer
    Gainsky Pty Ltd

Manufacturer

Gainsky Pty Ltd