Events

Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software 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-2015-RN-00335-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00335-1
  • 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 qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller than the esv calculated by manual tracing without the use of qlab. 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 qlab. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.An incorrect ejection fraction calculation could lead to misdiagnosis and/or delayed or incorrect therapy if healthcare providers make clinical decisions based solely on these measurements, without considering other available clinical data.
  • 조치
    Philips is providing temporary work instructions for users to follow until a software upgrade to QLAB Version 10.2 or higher is completed. This action has been closed-out on 12/08/2016.

Device

Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcele...
  • 모델명 / 제조번호(시리얼번호)
    Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera softwareARTG number: 170658
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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