Events

Device Recall Philips Medical Systems IntelliVue Information Center 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 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
    45843
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0451-2008
  • 사례 시작날짜
    2007-11-13
  • 사례 출판 날짜
    2007-12-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66252
  • 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
    Arrhythmia Detector and Alarm - Product Code MHX
  • 원인
    Alarm failure : if changes are made to the caregroup editor configuration, care group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the care group.
  • 조치
    Philips Medical notified customers by letter dated November 2007 titled : Urgent Medical Device Correction Notice. Customers will be instructed to follow the Procedure to Mitigate Risk section * of the notice while they await the correction of their devices with a mandatory software upgrade to be performed by service representatives. * (no changes are to be made to the Caregroup Editor configuration on any system. If changes have already been made to the configuration prior to receipt of this notification, turn each bedside monitor "off " and then "on" in order to reset the system-Customer Care Contact telephone 1-800-722-9377)

Device

Device Recall Philips Medical Systems IntelliVue Information Center
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 4711A00132 4725A02724 4711A00354 4725A02791 4716A00562 4725A02897 4717A00702 4725A02927 4717A00703 4725A03255 4717A00705 4732A03719 4717A00706 4732A03725 4717A00724 4732A03764 4717A00725 4732A03765 4717A00799 4732A03766 4717A00857 4732A04028 4718A00957 4732A04031 4718A01077 4732A04134 4718A01078 4732A04178 4718A01120 4732A04400 4718A01121 4732A04623 4718A01454 4732A04671 4721A01670 4732A04675 4721A01711 4732A04746 4721A01731 4732A04868 4721A01773 4732A04869 4721A01797 4732A04870 4721A01828 4732A04871 4721A01919 4732A04872 4721A01993 4732A04873 4721A01994 4732A04874 4721A01997 4732A04875 4721A02164 4732A04876 4725A02354 4732A04877 4732A04890 4732A04896
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.
  • 제품 설명
    Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA