Uronav, Transperineal option - Stepper with Stand(stereotactic accessory for use with clinical imaging systems) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-00172-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-02-03
  • 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
    A problem has been detected in the transperineal stepper with stand. the stand and the stepper have some sharp edges which can cause cuts to operator’s fingers or arms.
  • 조치
    Philips is advising users to be aware that there are edges on the Stepper that can cause minor cuts until the repair is performed. A PhiIips/Invivo representative will organise a convenient time to perform the repair on site. This action has been closed-out on 06/07/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Uronav, Transperineal option - Stepper with Stand(stereotactic accessory for use with clinical imaging systems)Model Number: 980603113091Serial Numbers 1, 2 or 3ARTG Number: 230930
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA