Events

Device Recall GE Precision XR/a 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
    49533
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1713-2008
  • 사례 시작날짜
    2007-03-29
  • 사례 출판 날짜
    2008-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73745
  • 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
    X-Ray System - Product Code KPR
  • 원인
    The actual average illuminance for the collimators are approximately 140-lux. this does not meet the 160-lux requirement. ge will be correcting the units by replacing all collimators.
  • 조치
    GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008.

Device

Device Recall GE Precision XR/a
  • 모델명 / 제조번호(시리얼번호)
    42948HL0, 42949HL8, 43054HL6, 43055HL3, 43056HL1, 43057HL9, 43132HL0, 43133HL8, 43134HL6, 43135HL3, 43201HL3, 43202HL1, 43203HL9, 44605HL4, 44606HL2, 44607HL0, 44608HL8, 44609HL6, 44610HL4, 44681HL5, 45046HL0, 45047HL8, 45048HL6, 45128HL6, 45129HL4, 45130HL2, 45131HL0, 48119HL2, 48120HL0, 48121HL8, 48122HL6, 48123HL4, 48124HL2, 48125HL9, 48126HL7, 48127HL5, 48128HL3, 48164HL8, 48181HL2, 48274HL5, 48276HL0, 48277HL8, 48278HL6, 48680HL3, 48682HL9, 48683HL7, 48684HL5, 48685HL2, 48686HL0, 48687HL8, 48688HL6, 48689HL4, 48876HL7, 48877HL5, 48878HL3, 48995HL3, 48997HL1, 48998HL9, 49000HL3, 49208HL2, 49209HL0, 49210HL8, 49211HL6, 49391HL6, 49392HL4, 49393HL2, 49395HL7, 49494HL8, 49496HL3, 49497HL1, 49498HL9, 49499HL7, 49500HL2, 49501HL0, 49502HL8, 49503HL6, 49681HL0, 49682HL8, 49683HL6, 49684HL4, 49685HL1, 49686HL9, 49687HL7, 49688HL5, 49850HL1, 49851HL9, 49852HL7, 49853HL5, 49855HL0, 49856HL8, 49857HL6, 50027HL2, 50028HL0, 50029HL8, 50030HL6, 50031HL4, 50177HL5, 50178HL3, 50179HL1, 50180HL9, 50321HL9, 50322HL7, 50323HL5, 50324HL3, 50444HL9, 50445HL6, 50446HL4, 50447HL2, 50448HL0, 50449HL8, 50450HL6, 50451HL4, 50452HL2, 50453HL0, 50790HL5, 50791HL3, 50792HL1, 50793HL9, 50794HL9, 50795HL4, 50797HL0, 50798HL8, 50801HL0, 51143HL6, 51144HL4, 51145HL1, 51147HL7, 51486HL9, 51487HL7, 51488HL5, 52014HL8, and 70RD05001
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of CA, DE, FL, GA, ID, IL, KS, KY, MD, MI, MO, MT, NC, NJ, NM, NY, OH, PA, SC, TX, UT, VA, and WV, and countries of Australia, Canada, China, France, Germany, Greece, Italy, Korea, Poland, Saudi Arabia, United Kingdom, and Venezuela.
  • 제품 설명
    GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
  • Manufacturer
    GE Healthcare

Manufacturer

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