Events

YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-2012-RN-01151-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01151-1
  • 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
    Maquet has identified a potential issue with the release lever of the screw tension mechanism, whereby it may be difficult to set or maintain the desired traction. this issue can occur during use with any patient population, however it is most likely to occur when setting higher tensions.
  • 조치
    A Maquet authorised Service Engineer is to arrange an appointment to assess the affected devices and to replace the release lever. Customers are advised to be aware that they may experience difficulty with the tension mechanism until the repair/replacement activity is performed.

Device

YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)
  • 모델명 / 제조번호(시리얼번호)
    YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)Part Number: 1433.62A1; Serial number: 001-107Part Number: 1433.62A0; All serial numbersARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd