Events

Philips EPIQ 5 Ultrasound System 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-00360-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00360-1
  • 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
    The epiq 5 will report incorrect doppler velocities if users use high pulse repetition frequency (hprf) with multiple sample volume gates.While in high pulse repetition frequency (hprf) in ‘display zoom velocity scale’ using manual spectral doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. the erroneous values are reported on the reports page and in dicom sr if exported and include the following velocities and calculations:general imaging, (gi)-- peak systolic velocity (psv)- end diastolic volume (edv)- minimum diastolic velocity (mdv)- time averaged peak velocity (tapv)- time averaged mean velocity (tamv)affected gi calculations:- s/d (ratio of peak systolic velocity / peak diastolic velocity)- resistivity index (ri)- pulsatility index (pi).
  • 조치
    Philips has corrected the issues in software version 1.1.2. Philips is advising their customers to not use HPRF in doppler mode until the affected system is upgraded to version 1.1.2. This action has been closed-out on 12/02/2016.

Device

Philips EPIQ 5 Ultrasound System

Manufacturer

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