Device Recall GE Healthcare Precision 500D

  • 모델명 / 제조번호(시리얼번호)
    Mfg. Lot or Serial # System ID 00000034206YY3 229353TR2 00000146304MO1 423778ERM4 Not Available 817255NHPD1
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
  • 제품 설명
    Precision 500D
  • Manufacturer
  • 1 Event

제조사

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

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  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # 00000002243MC4 00000017545MC9 00000001018MC1 00000001083MC5 00000003942MC0 00000001707MC9 00000001110MC6 0000000B2055KJ 00000001283MC1 00000002163MC4 00000002189MC9 00000002190MC7 00000000895MC3 00000001165MC0 00000001107MC2 00000004224MC2 00000001902MC6 00000004278MC8 00000000930MC8 00000000945MC6 00000004162MC4 00000004211MC9 00000001560MC2 00000001293MC0 00000003575MC8 00000003619MC4 00000001204MC7 00000001205MC4 00000003702MC8 00000003885MC1 00000001207MC0 00000004018MC8 00000001128MC8 00000004382MC8 00000004578MC1 00000001385MC4 00000003406MC6 00000000868MC0 00000000949MC8 00000001369MC8 00000003932MC1 00000001006MC6 00000001361MC5 00000001441MC5 00000000888MC8 00000001097MC5 00000003622MC8 00000001058MC7 00000004422MC2 00000001511MC5 00000001614MC7 00000001245MC0 00000003700MC2 00000003701MC0 00000001360MC7 00000001155MC1 00000001588MC3 00000003617MC8 00000002387MC9 00000003928MC9 00000001005MC8 00000001011MC6 00000003479MC3 00000001223MC7 00000001316MC9 00000001105MC6 00000003697MC0 00000001613MC9 00000000986MC0 00000001443MC1 00000001166MC8 00000002375MC4 00000001300MC3 00000004381MC0 00000000915MC9 00000002146MC9 00000003943MC8 00000001412MC6 00000001507MC3 00000001483MC7 00000001182MC5 00000004588MC0 00000003658MC2 00000001017MC3 00000001513MC1 00000002034MC7 00000002356MC4 00000000971MC2 00000004085MC7 00000003784MC6 00000001262MC5 00000001875MC4 00000004670MC6 00000003968MC5 00000001450MC6 00000001873MC9 00000004383MC6 00000004419MC8 00000004645MC8 00000001108MC0 00000001643MC6 00000001841MC6 00000000865MC6 00000004061MC8 00000001840MC8 00000001414MC2 00000001972MC9 00000001531MC3 00000001705MC3 00000001748MC3 00000001404MC3 00000001440MC7 00000001709MC5 00000001229MC4 00000000913MC4 00000001534MC7 00000001187MC4 00000001477MC9 00000004277MC0 00000002238MC4 00000003620MC2 00000003933MC9 00000001465MC4 00000001545MC3 00000002147MC7 00000002378MC8 00000003761MC4 00000002106MC3 00000004379MC4 00000001013MC2 00000001471MC2 00000001702MC0 00000004107MC9 00000003785MC3 00000001353MC2 00000003585MC7 00000001608MC9 00000001609MC7 00000004020MC4 00000002357MC2 00000003934MC7 00000001832MC5 00000001908MC3 00000004502MC1 00000002262MC4 00000002382MC0 00000001464MC7 00000001842MC4 00000004017MC0 00000001475MC3 00000004504MC7 00000002150MC1 00000002264MC0 00000001299MC7 00000004086MC5 00000001641MC0 00000002373MC9 00000001563MC6 00000001220MC3 00000001973MC7 00000001433MC2 00000001439MC9 00000004055MC0 00000018721MC1 00000001126MC2 00000001159MC3 00000000836MC7 00000001341MC7 00000001481MC1 00000001163MC5 00000002242MC6 00000003735MC8 00000001562MC8 00000001586MC7 00000004582MC3 00000000835MC9 00000002240MC0 00000002103MC0 00000002035MC4 00000001279MC9 00000001278MC1 00000001510MC7 00000004063MC4 00000002377MC0 00000002105MC5 00000002185MC7 00000003660MC8 00000001295MC5 00000001704MC6 00000001284MC9 00000001310MC2 00000003882MC8 00000001094MC2 00000001219MC5 00000000897MC9 00000003758MC0 00000000920MC9 00000001711MC1 00000003974MC3 00000003938MC8 00000002161MC8 00000000879MC7 00000001572MC7 00000003509MC7 00000001096MC7 00000003703MC6 00000004425MC5 00000004109MC5 00000004201MC0 00000001642MC8 00000000961MC3 00000001183MC3 00000001718MC6 00000002107MC1 00000001249MC2 00000000979MC5 00000004163MC2 00000002266MC5 00000002208MC7 00000004062MC6 0000004062MC6A 00000001752MC5 00000001976MC0 00000002383MC8 00000003698MC8 00000002036MC2 00000004579MC9 00000001189MC0 00000001425MC8 00000003407MC4 00000001719MC4 00000000976MC1 00000003939MC6 00000001130MC4 00000001260MC9 00000001624MC6 00000002148MC5 00000002358MC0 00000001090MC0 00000003409MC0 00000001874MC7 00000001362MC3 00000004276MC2 00000001489MC4 00000001088MC4 00000001398MC7 00000001905MC9 00000003507MC1 00000001716MC0 00000001833MC3 00000000943MC1 00000001485MC2 00000003975MC0 00000001456MC3 00000000896MC1 00000000919MC1 00000003586MC5 00000004564MC1 00000003842MC2 00000002370MC5 00000002376MC2 00000001469MC6 00000002187MC3 00000004015MC4 00000002360MC6 00000001835MC8 00000003786MC1 00000002038MC8 00000001008MC2 00000002384MC6 00000003876MC0 00000002236MC8 00000000912MC6 00000004599MC7 00000000980MC3 00000001111MC4 00000001224MC5 00000000964MC7 00000003811MC7 00000001559MC4 00000003935MC4 00000001532MC1 00000001185MC8 00000000916MC7 00000000969MC6 00000001156MC9 00000001103MC1 00000001177MC5 00000001492MC8 00000001906MC7 00000001966MC1 00000004384MC4 00000004587MC2 00000003845MC5 00000002237MC6 00000003544MC4 00000001657MC6 00000001209MC6 00000000935MC7 00000004600MC3 00000001487MC8 00000001329MC2 00000001164MC3 00000001901MC8 00000000978MC7 00000001175MC9 00000001647MC7 00000001710MC3 00000001591MC7 00000001565MC1 00000001876MC2 00000004058MC4 00000001463MC9 00000004584MC9 00000001426MC6 00000003969MC3 000000001509MC 00000001176MC7 00000004672MC2 00000001594MC1 00000001230MC2 00000003884MC4 00000004586MC4 00000001566MC9 00000001231MC0 00000001401MC9 00000000867MC2 00000002162MC6 00000003623MC6 00000001014MC0 00000001015MC7 00000001399MC5 00000001466MC2 000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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.
  • 제품 설명
    GE Healthcare Precision 500D Classical R & F system.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Mfg Lot or Serial # System ID 00000007820HL1 757736WDR1 00000075975HL3 WDR1-RF1 00000075976HL1 530BGDR 00000075977HL9 210MTFP 00000075979HL5 337470WDR2 00000075981HL1 205408WDR1 00000075982HL9 WDR1-RF2 00000075983HL7 337470WDR1 00000075984HL5 LLPM500D 00000076011HL6 434654RM4 00000076012HL4 585596FPD1 00000076013HL2 520GV500D 00000076014HL0 781624HSSHFP 00000076015HL7 954JDCHWDR1 00000076016HL5 503391SKY 00000076018HL1 954JDCHWDR2 00000076019HL9 518926DRRM4 00000076021HL5 954265WDR1 00000076022HL3 207795CM3WDR 00000076023HL1 719285P500 00000076026HL4 540DALEVILLE 00000076027HL2 410392RAD 00000076028HL0 318495WDR1 00000076285HL6 0002952447 00000076286HL4 918579PROTEUS 00000076287HL2 518926FLRM3 00000076288HL0 ORMCP500DIG 00000076290HL6 713791P500FP4 00000076379HL7 518243WDR1 00000076380HL5 504873FP1 00000076381HL3 435722GDXR 00000076487HL8 989224FLSHPD1 00000076489HL4 229924P500 00000076490HL2 405752RF2 00000076643HL6 COR481360 00000076644HL4 713UTPROTEUS 00000076646HL9 518243WDR1 00000076647HL7 706754EF1 00000076648HL5 COR481360 00000076649HL3 518243WDR1 00000076650HL1 918273CNNP1 00000076651HL9 918434P500 00000076652HL7 714827P500 00000076986HL9 325574WDRRM2 00000076990HL1 878WDR 00000076991HL9 919RALCPFLASH2 00000076995HL0 912384FP5 00000076996HL8 540829RF1DR 00000076997HL6 305LEON27FLGD 00000076998HL4 205877BPRF1 00000077642HL7 989224FLSHPD1 00000077644HL3 240566EDWDR1 00000077647HL6 925370PAD 00000077648HL4 603524500D 00000077649HL2 618443SFP 00000077652HL6 540CULRF2 00000077653HL4 501202WDR14 00000078002HL3 760873FP2 00000078196HL3 318259RM2 00000078201HL1 757736WDR1 00000078669HL9 419538RAD 00000078670HL7 601928PXR 00000078671HL5 512LRMCRF 00000079045HL1 417347P500 00000079046HL9 608364PRFPCL 00000079047HL7 218828WDR1 00000079048HL5 269637FP 00000079049HL3 281274P5DGR 00000079457HL8 501202BNLER 00000079460HL2 507434DR1 00000079461HL0 570455GDXR 00000079662HL3 312CMP500D2 00000079663HL1 330841AND 00000080016HL9 724285WDR 00000080196HL9 325574WDRRM1 00000080556HL4 315425A320WDR1 00000080560HL6 301874UBWDR1 00000081032HL5 281477MWBP500D 00000081033HL3 412372DD1 00000081034HL1 608356P500 00000081035HL8 504896R2P500 00000081036HL6 252847EDDIG1 00000081037HL4 252847EDDIG2 00000081038HL2 504873FPR4 00000083548HL8 314919JDR1 00000083876HL3 732840WDROP 00000083877HL1 636239DR2 00000083878HL9 740383WDR1 00000083881HL8 636239MOBDR1 00000084098HL3 404778FPAD 00000084101HL5 0002996020 00000084206HL2 906293DIG2 00000084208HL8 304252FCPROT 00000084209HL6 518292RM4DR 00000084211HL2 781306FP 00000084313HL6 724983500D 00000084314HL4 904271FP1 00000084315HL1 206288WDR1 00000084551HL1 505609FLASH1 00000084552HL9 240566DF1 00000084553HL7 SLWPRO 00000084554HL5 330841PXD 00000084556HL0 330841RFD 00000084989HL3 409212GEDR1 00000085226HL9 828456FLSHPD1 00000085228HL5 732840WDRER1 00000085230HL1 641228WDR1 00000085231HL9 770400WDR1 00000085385HL3 412367WDR 00000085386HL1 815395OSFER1D 00000085387HL9 SLWP500 00000085389HL5 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, TN ,KY, TX, UT, VA, WA, WV, WI and WY., and the countries of ARGENTINA, AUSTRALIA, CANADA, FRANCE, IRELAND, ITALY, JORDAN, ROMANIA, RUSSIA, UNITED ARAB EMIRATES and UNITED KINGDOM.
  • 제품 설명
    GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). || The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.
  • Manufacturer