Events

Vigilance II Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Edwards Lifesciences, Llc 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
    52807
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0942-2012
  • 사례 시작날짜
    2008-09-12
  • 사례 출판 날짜
    2012-02-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84048
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Computer, diagnostic, pre-programmed, single-function - Product Code DXG
  • 원인
    Edwards lifesciences has made the decision to initiate a field corrective action for the edwards vigilance ii model: software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate injectate cardiac output (ico) measurements.
  • 조치
    Edwards initiated two Urgent Product Notification - Action Required letters to all affected customers. The letters identified the affected product, problem, and actions to be taken. The letters instructed users to immediately discontinue use of in-line temperature probes for Intermittent Cardiac Output (ICO) measurements on the Vigilance II instrument and recommends use of the bath probe only (model 9850A) to measure the temperature of the injectate solution for ICO calculations, until software update have been completed. Customers were instructed to complete and return a software upgrade form to Edwards as record of completion. For questions call Edwards Technical Support department at 800-822-9837.

Device

Vigilance II Monitor
  • 모델명 / 제조번호(시리얼번호)
    Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73.  Serial numbers: VG000031 to VG007468
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide Distribution (USA) - and the countries of: Argentina, Australia/ New Zealand, Brazil, Canada, China, Columbia, Ecuador, Europe, Indonesia, Japan, Korea, Macao, Malaysia, Mexico, Middle East, Peru, Puerto Rico, Singapore, Thailand, Taiwan and Venezuela
  • 제품 설명
    Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, || 00.71, 00.73. || Product Usage: || The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • 제조사 주소
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA