Events

Precison 500D 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, 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
    69322
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0010-2015
  • 사례 시작날짜
    2014-09-05
  • 사례 출판 날짜
    2014-10-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130227
  • 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, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    Ge healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead video monitor to the tray assembly on a single monitor suspension. this issue affects the precision 500d x-ray imaging systems.
  • 조치
    Consignees were sent on 9/5/2014 a GE Healthcare "Urgent Medical Device Letter" GE Ref:10893, dated September 5, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology & Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in USA call 800-437-1171, for other countries contact your local GE Healthcare Service Representative.

Device

Precison 500D
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # System ID 00000015997MO7 260347RF 00000149474MO9 423778ENRF1 00000149476MO4 216343R1 00000149477MO2 423778ERF1 00000149478MO0 407296PRE 00000149479MO8 765482WR2 00000149480MO6 478633PDI3 00000149481MO4 404321P500D 00000149482MO2 435865500D 00000149483MO0 210297NCRF1 00000149484MO8 334705EA3 00000149485MO5 314577GC64 00000149486MO3 423224RF1 00000149487MO1 847432HP8 00000149488MO9 423778ERF2 00000149489MO7 210616MCTRF 00000149490MO5 773633EP500 00000149491MO3 763520N8 00000149492MO1 773CMHCSRF 00000149493MO9 904202RF 00000149495MO4 208557RM1 00000149496MO2 515226RF 00000149498MO8 847535RF1 00000149499MO6 704210RX5 00000149500MO1 515226RF2 00000149501MO9 970244AMPRF2 00000149502MO7 215750PRECIS1 00000149503MO5 504447P500 00000149505MO0 602344RM7 00000149506MO8 609584RM1 00000149507MO6 603433PRF3 00000149508MO4 828766R2 00000149509MO2 210297SEBRF3 00000149510MO0 651232RF4 00000149511MO8 502868RF1 00000149512MO6 314525SARM2 00000149513MO4 515247RF1 00000150005M00 308398RF 00000152264MO8 708783RM1 00000152265MO5 319283M500D 00000152266MO3 608873RF 00000152267MO1 210297BMCRF11 00000152269MO7 540776RF1 00000152270MO5 409727MJRF1 00000152276MO2 601936RF1 00000152277MO0 409985PRF3 00000152278MO8 617636RMD 00000152279MO6 760FCI2500D 00000152280MO4 973971RF8 00000152281MO2 651480RF1 00000152282MO0 832355SLT3 00000152283MO8 903232LRP500 00000152285MO3 978521MVRF4 00000152286MO1 760830500D 00000152290MO3 304379RF 00000152292M09 260920RF 00000152295MO2 850325RF4 00000152295MO7 850325RF3 00000152296MO0 314577GC31 00000152298M06 320693PREC 00000152302MO6 972698P500D3 00000152307M05 781744RF3 00000152311MO7 972566P500D1 00000152312MO5 720225RM3 00000152313MO3 720225RM1 00000152316MO6 215750PRECIS2 00000152317MO4 270389RF 00000152318MO2 956632MCRF1 00000152321MO6 847570RF10 00000152322MO4 816348BRF1 00000152323MO2 913498MR2 00000152324MO0 662536RF1 00000152325MO7 847872RF1 00000152327MO3 812450RF12 00000152328M01 304792PRE1 00000152329MO9 913541HPR3 00000152330MO7 636916BRM4 00000152331M05 650723RF2 00000152332MO3 903731PRP500 00000152336MO4 256782P500 00000152337MO2 435251RM1 00000152338MO0 404778WC2 00000152340MO6 605322RM2 00000152342MO2 LIJ016996 00000152343MO0 903614SM500 00000152344MO8 301896RF2 00000152345MO5 509575YRX6 00000152346MO3 617726PR35A 00000152347MO1 570546RF2 00000152351MO3 570271F1 00000152352MO1 434982RF1 00000152353MO9 843789VR3 00000152356MO2 863763RM4 00000152357MO0 770824HRF2 00000152358MO8 850494WF4 00000152359MO6 704487CRRF1 00000152360MO4 860444P500 00000152361MO2 253968RM9500D 00000152363MO8 770793P500D 00000159964MO6 813870500D 00000159965MO3 617732P16 00000159966MO1 505863XRM1 00000159967MO9 252466CP500D 00000159968MO7 395PRM2 00000159969MO5 828298RF4 00000159972MO9 775SMP500D 00000159973MO7 505538RF2 00000159974MO5 773IMP500R5 00000159975MO2 605333RM6 00000159976MO0 985875P500 00000159977MO8 210704SRF2 00000159981MO0 847490PER 00000159983MO6 972420LR6 00000159985MO1 414527PR500 00000159987MO7 973989RM4 00000159989MO3 217528SCRF3 00000159990MO1 270798PREC2 00000159992MO7 662716RF1 00000159993MO5 LIJ017457 00000159994MO3 972731FL1 00000159995MO0 603225C1 00000159998MD4 608260RF 00000159999MO2 713636LBJ7 00000160001MO4 603225C2 00000160002MO2 404712PR2 00000160003MD0 304473RF1 00000160005MO5 773IMP500R10 00000160006MO3 409899RF2 00000160008MO9 352265RM7 00000160009MO7 775885500D 00000160010MO5 217528SCRF4 00000160012MO1 409899RF3 00000160013MO9 409899S05 00000160014MO7 318254DRF3 00000160016MO2 419354P500 00000160017MO0 901722RF1 00000160018MO8 817430TCPD2 00000160019MO6 417269SXP8 00000160025MO3 847535GLRF2 00000160027MO9 210575MSTH4 00000160028MO7 864560IP2F 00000160028MO7 864560IP2R 00000160029MO5 870494PREC 00000160031MO1 972394500D2 00000160032MO9 814452PREC1 00000160033MO7 626359RF2 00000160034MO5 361857DPR2 00000160035MO2 610526PRECIS1 00000160037MO8 843479P500 00000160038MO6 978937LRF2 00000160039MO4 814437RF1 00000160040MO2 843387P500 00000160041MO0 814437RF2 00000160042MO8 772589RM3 00000160043MO6 970565RM1 00000160044MO4 209826500D 00000160045MO1 626359RF1 00000160046MO9 940937RF 00000160047MO7 361595SK2 00000160048MO5 409899RF1 00000160049MO3 541523EP500 00000160050MO1 847535GLRF1 00000160051MO9 972731FL2 00000160052MO7 972394500D1 00000160053MO5 248898P500 00000160054MO3 281588RF2 00000160055MO0 404325EFL2 00000160057MO6 562868RM1 00000160058MO4 281348P5001 00000160059MO2 617732P15 00000160061MO8 864560IP3F 00000160062MO6 713636LBJ8 00000160063MO4 573875CR1 00000165915MO0 804225RCRM2 00000165917MO6 864487UPR1 00000165918MO4 203852RM3 00000165923MO4 RAVENROCK1 00000165925MO9 504873TR5P 00000165926MO7 203852RM2 00000165927MO5 856582P500 00000165930MO9 706494H500 00000165931MO7 662779RF2 00000165932MO5 808433500D1 00000165933MO3 314996MBRM1 00000165936MO6 216844PREC1 00000165937MO4 508862CCH4 00000165938MO2 985230DCRF4 00000165939MO0 828213SJRF2 00000165940MOB 617726PR32A 00000165941MO6 985230DCRF3 00000165943MO2 732321P501 00000165944MO0 305824P500 00000165945M07 417269CMP2 00000165947M03 417269SXP2 00000165948MO1 318813FWR1 00000165949MO9 316858RF500 00000165951MO5 617732P17 00000165952MO3 361985RF1 00000165954MO9 717272RF2 00000160000MO6 506857P500 00000160026MO1 519663PR500 00000165916MO8 519685PR500 00000160020MO4 PC7479XR03 00000152350MO5 00105FLU01
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM.
  • 제품 설명
    GE Healthcare Precision 500D, Classical R&F; System. || Product Usage: || The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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