Device Recall GE Innova 2100IQ 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare 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
    44936
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1088-2007
  • 사례 시작날짜
    2006-06-06
  • 사례 출판 날짜
    2007-09-28
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Fluoroscopic Imaging System, - Product Code MQB
  • 원인
    The systems do not contain a certification label on the c2 cabinet (beam-limiting control).
  • 조치
    Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices.

Device

  • 모델명 / 제조번호(시리얼번호)
    00000459256BU4, 00000459553BU4, 00000459554BU2, 00000459555BU9, 00000459556BU7, 00000459557BU5, 00000460056BU5, 00000460057BU3, 00000460058BU1, 00000460059BU9, 00000460060BU7, 00000460063BU1, 00000460065BU6, 00000460066BU4, 00000460067BU2, 00000461642BU1, 00000461643BU9, 00000461644BU7, 00000461645BU4, 00000462898BU8, 00000462899BU6, 00000462900BU2, 00000462901BU0, 00000462902BU8, 00000462903BU6, 00000462904BU4, 00000462905BU1, 00000462906BU9, 00000462907BU7, 00000463613BU2, 00000463630BU4, 00000463631BU2, 00000463632BU0, 00000463633BU8, 00000463634BU6, 00000463636BU1, 00000463637BU9, 00000463638BU7, 00000463639BU5, 00000463841BU7, 00000467440BU4, 00000467441BU2, 00000467442BU0, 00000467443BU8, 00000467444BU6, 00000467445BU3, 00000467446BU1, 00000467447BU9, 00000467448BU7, 00000467449BU5, 00000467451BU1, 00000469541BU7, 00000469542BU5, 00000469543BU3, 00000469544BU1, 00000469545BU6, 00000469546BU6, 00000469547BU4, 00000469548BU2, 00000469549BU0, 00000469550BU8, 00000470643BU8, 00000470644BU6, 00000470645BU3, 00000470646BU1, 00000470647BU9, 00000470648BU7, 00000470649BU5, 00000470650BU3, 00000470651BU1, 00000470652BU9, 00000471493BU7, 00000471494BU5, 00000471495BU2, 00000471496BU0, 00000471497BU8, 00000471498BU6, 00000471499BU4, 00000471500BU9, 00000471501BU7, 00000471502BU5, 00000472676BU6, 00000477489BU9, 00000477490BU7, 00000477491BU5, 00000477492BU3, 00000477493BU1, 00000477494BU9, 00000477495BU6, 00000477496BU4, 00000477497BU2, 00000477498BU0, 00000477893BU2, 00000479230BU5, 00000479231BU3, 00000479232BU1, 00000479233BU9, 00000479234BU7, 00000479235BU4, 00000479236BU2, 00000479237BU0, 00000479238BU8, 00000479239BU6, 00000479937BU5, 00000479945BU8, 00000479946BU6, 00000479947BU4, 00000479948BU2, 00000479949BU0, 00000479950BU8, 00000479951BU6, 00000479952BU4, 00000479953BU2, 00000479954BU0, 00000482511BU3, 00000482512BU1, 00000482513BU9, 00000482514BU7, 00000482515BU4, 00000482516BU2, 00000482517BU0, 00000482518BU8, 00000482519BU6, 00000482520BU4, 00000484054BU2, 00000485072BU3, 00000485074BU9, 00000485075BU6, 00000485076BU4, 00000485077BU2, 00000485078BU0, 00000485079BU8, 00000485080BU6, 00000485081BU4, 00000487465BU7, 00000487466BU5, 00000487469BU9, 00000487470BU7, 00000487471BU5, 00000487472BU3, 00000487473BU1, 00000487474BU9, 00000491019BU6, 00000491020BU4, 00000491021BU2, 00000491022BU0, 00000491023BU8, 00000491025BU3, 00000491027BU9, 00000491028BU7, 00000491032BU9, 00000492823BU0, 00000492824BU8, 00000492825BU5, 00000492827BU1, 00000492828BU9, 00000492830BU5, 00000492831BU3, 00000494960BU8, 00000504480BU5, 00000508755BU6, 00004600057BU3
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, and United Kingdom.
  • 제품 설명
    GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.
  • Manufacturer

Manufacturer

  • 제조사 주소
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA