Events

Image Processing System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 General Electric Med Systems 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
    34516
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0854-06
  • 사례 시작날짜
    2004-10-08
  • 사례 출판 날짜
    2006-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43994
  • 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
    System, Image Processing, Radiological - Product Code LLZ
  • 원인
    Display in fused mode- viewer allows 2 studies ( pet/ct) registered in the same spatial domain to be viewed simultaneously. these 2 images should be visually aligned to a precision of less than 1/2 pet voxel. a problem associated with this version of software may introduce a shift of up to 1.5 pet voxels, which can be as much as 8 mm with certain zoom factors.
  • 조치
    An Urgent Safety Notice letter, dated October 8, 2004,(5121309-147, rev.E) was distributed to affected customers and a validated software patch that corrected the problem was installed on affected systems via Field Modification Instruction (FMI) 80114.

Device

Image Processing System
  • 모델명 / 제조번호(시리얼번호)
    100943VP0, 67392II1, 36521VE3, 70827VE1, 419453BU6436332BU1, 70800VE8, 44586VE6, 341GE8, 97197VP8, 99813VP8, 97983VP1, 70820VE6, 58626VE3, 70795VE0, FRB3510J25, 58630VE5, 58624VE8, 58589VE3, 7823VE0, 44579VE1, 44597VE3, 44585VE8, 25125VE6, 425022BU1, 70796VE8, 93086VE7, 37621BU4, 76906VE7, 76899VE4, 70798VE4, 65504VE3, 65603VE3, 36543VE7, 58628VE9, 70811VE5, 44584VE1, 44581VE7, FRB3430VBM, 44589VE0, 44598VE1, 44582VE5, 44594VE0, 72740VE4, 1189GE0, 2030GE5, 2085GE0, 2025GE5, 72477II3, 72480II7, 343GE4, 97203VP4, 98272VP8, 423277BU3, 349GE1, 425018BU9, FRB3300M6G, 99699VP1, 98371VP8, 101216VP0, 425015BU5, 237GE8, 364GE0, 339GE2, 101196VP4, 419382BU7, 419383BU5, 366GE5, 367GE3, 357GE4, 2085GE9, 419457BU7, 25128VE0, 98436VP9, 99981VP3, 36513VE0, 98623UP2, 101000VP8, 2028GE9, 2799GE5, 1089GE2, 419450BU2, 101280VP6, 67269VE1, 100855VP6, 66250II2, 346GE7, 363GE2, 345GE9, 1073VP5, 101170VP9, 98516VP8, 2802GE7, 419356BU1, 66244II5, 1487GE8, 67389II7, 365GE7, 425021BU3, 383GE0, 25132VE2, 101334VP1, 95972VP6, 419449BU4, 2031GE3, 2800GE1, 36517VE1, FRB33605L9, 1024GE9, 95307VP5, 102235VP9, 102232VP6, 425204BU5, 1124GE7, 1122GE1, 419455BU1, 419456BU9, 102220VP1, 102555VP0, 97622VP5, 72249II6, 67210VE5, FRB33605KX, 419257BU1, 95268VP9, 338GE4, 101404VP2, 2090GE9, 2087GE5, 101308VP5, 101251VP7, 421989BU5, 342GE6, 99627VP2, 97933VP6, 98653VP9, 66249II4, 72479II9, 25126VE4, 356GE6, 25130VE6, 65450VE9, DE31500056, 347GE5, 421367BU4, 100912VP5, 25123VE1, 25124VE9, 99867VP4, DE24600031, 99910VP2, 101246VP7, 419357BU9, 101171VP7, 102825VP7, 100664VP2, 102856VP2, 424101BU4, 425020BU5, 354GE1, 36518VE9, 100885VP3, 2801GE9, USV41104ST, 2091GE7, USV41103MJ, 99994VP6, 102133VP6, 419549BU1, 25137VE1, 102078VP3, 425351BU4, 1066GE0, 98816VP2, 97591VP2, 99631VP4, 423318BU5, 2086GE7, 97905VP4, 100690VP7, 350GE9, 25139VE7, 1120GE5, 100001VP7, 2084GE2, 391228BU4, 101190VP7, 99909VP4, 1123GE9, 2803GE5, 98474VP0, 25127VE2, 67384II8, 98815VP4, 101288VP9, 101287VP1, 66241II1, 25134VE8
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in 32 states: AK, AL, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV; Australia, Belgium, Brazil, Canada, Switzerland, Chile, Nigeria, China, France, Egypt, Ireland, Israel, Japan, Korea, the Netherlands, Norway, New Zealand, Phillipines, Sweden, and Taiwan.
  • 제품 설명
    Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
  • Manufacturer
    General Electric Med Systems LLC

Manufacturer

General Electric Med Systems LLC
  • 제조사 주소
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA