Events

Philips Ultrasound QLAB versions 10.0 and 10.1 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-00837-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00837-1
  • 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
    Philips healthcare has discovered a problem in the philips ultrasound qlab version 10.0 and 10.1 when used on a picture archiving and communication system (pacs) or with third party pacs integration that could result in the erroneous calculation of ejection fraction (ef) from the results of a2dq and acmq patient exams. an incorrect ef calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
  • 조치
    Philips has corrected this issue in QLAB version 10.2, and is sending a CD with QLAB version 10.2 to affected customers. Until your software can be upgraded to QLAB version 10.2, end users can avoid the issue by: - Ensuring that a2DQ patient exams include both biplane views for AP2 and AP4. When both biplane views are present, EF measurements will not persist from measurements taken in a prior patient exam. - Ensuring that aCMQ patient exams include all three views (AP2, AP3, and AP4). When all three views are present, measurements will not persist from measurements taken in a prior patient exam. This action has been closed-out on 03/06/2016.

Device

Philips Ultrasound QLAB versions 10.0 and 10.1
  • 모델명 / 제조번호(시리얼번호)
    Philips Ultrasound QLAB versions 10.0 and 10.1Part Numbers: 453561704771 and 453561728001ARTG Number: 100468
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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