Events

Philips Ultrasound Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps 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-2014-RN-01255-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-11-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01255-1
  • 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
    When using the q-station 3.0 auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller esv calculated by manual tracing without the use of q-station 3.0. correspondingly, the left ventricular ejection fraction (ef) calculated using these applications may be higher than the ef calculated by manual tracing without the use of q-station 3.0. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.
  • 조치
    Philips is providing instructions to assist end users to determine if they are affected by this issue. Philips has developed a software update to correct the issue. A CD with the new version of the software will be sent to all end users for installation. Until the software has been upgraded, the issue can be avoided by ensuring that left ventricular volumes and ejection fraction are calculated by using either the on-cart manual analysis package or off-cart manual analysis package for your primary assessment. This action has been closed-out on 5/08/2016.

Device

Philips Ultrasound Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA