Events

Device Recall Revolution XR/d 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical 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
    53158
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0003-2009
  • 사례 시작날짜
    2008-02-14
  • 사례 출판 날짜
    2009-09-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84808
  • 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
    Stationary X-ray System - Product Code KPR
  • 원인
    Ge healthcare has recently become aware of an error in the generator software on the revolution xr/d configured with hp 8200 pc consoles that reports a mas reading that is higher than is actually exposed to patients.
  • 조치
    Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Contact Information.

Device

Device Recall Revolution XR/d
  • 모델명 / 제조번호(시리얼번호)
    SYSTEM 418525XRD 905575XRD 630856QXI 847437GEXRD3 847437XRDCH 605622RAD 850208XRD 217223XRD 269657XRD 415600XRD3 724873XRDL 615342ERXRD 615342RM1 205939SVXRD 716250RAD1 919575FCI2 919575LSCI 724458XRD 850934XRD 303932XRD 303932XRD 760241XRD 256265XR2 256265XR3 256IXR1 251435XRD1 208743LXRDX 318675ACCR1 318675ACCR2 708783R8 602506XRD 724773XRDL 843573WAXRD 713605XRD 562424XRD 954987PED1 713790MMXRD1 281274XRD2 865481FTXRD 630236XRD 949364ER 210646LXRD 781344XRD 567661XRD 630978XRDE185 630978XRDE186 805494XRD 847429ERT 440816XRD1 253952XRD1 314251JDRM4 636947XRDER 205408SVXRD 813654XRD 715393XRD 330841XRD7 330841XRD9 209669XRD 209669XRD 812238UH2 216844PEDR2 910822VAXRD2 205387WDC 503315WOXRD 803776VR1 XQ0068 XK0002 XK0003 XQ0076 XK0005 XK0006 XK0007 XK0001 082407040266 082407160202 0853070321 0850070730 0850070733 0850070734 0850070735 0850070736 0850070731, and 0850070738.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiwan.
  • 제품 설명
    Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. || Intended for use in generating Tomographic images of human anatomy.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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