Devices

Device Recall Digital Fluoroscopic Imaging System

  • Model / Serial
    System ID Numbers:  388567772VASMET, 704384PHMCATH, 509946CATH2, 262687CL3, 318798CL1, 507385INN3100, 8189813100, 219877IN2 , 865512CL3, 704878CL31, 718250CATH1, 912486CATH1, DR3100, 417347FCV5, LVINOV4, 308865GIN2, 925779INNOVA408, 215576INNOVA1, 760242CATH1, 404686CRI3, 281420LAB23100, 541382CV3, 205783BCL5, 2035763100, 508941IN1, 843797TCL2, 361980INNOVA2, 214590PH3100, 303629CL4, 303629EP, 3027443100, 7018573100, 303788CL2, 239939CLA, 850862IN3100, 352333CATH1, 352333CATH2, 8184093100, 919731WMINOV, 305364P3100, 205877CCL1, 281440CL3, 208227CATH2, 2014183100, 7028533100, 865693CCL1, 609757IN3100, 6619483100, 219326IN31, 7022333100, 816969LSCATH, 209334LINNOVA1, 310319SM3100, 502587LAB1, 219877IN31, 9734293100, 215335INNOVA1, 239436CATH3, 239513CRLAB1, 8053703100, 615222H, 812858GWLAB1, 812858GWLAB2, 8014793100, 270688INN, 65049331, 850747BR3100, 6106483100, 8508573100, 850469BCV1, 207662CL4, 207879CL131, 951788INNOVA3, 951788INNOVA2, 541677MINNOVA1, 5033703100, 253968INNOVA, 254742KDCL1, 662377CV4, 412437INNOVA, 9202623100, 303425CL4, 2197573100, 228818VASC, 316651INNOVA31, 316962WCVC1, 316962WCVC2, 325428CATH1, 325428CATH3, 336832MCPV, 360456XCL3, 361857CATH1, 405272SCL2, 405372S3100, 405604D3100, 405840OIC3100, 406447VAIN3, 406543IN3, 413582C3100, 414447CL1, 414647CL1, 414649CL3, 414649CL4, 414805INNOVA1, 415925INV1, 417885JCL7, 417885JCL8, 423495MCL6, 423844CCL1, 478274CTH1, 502852INNOVA, 510797INV8, 512901NI3100, 516562INNOVA8, 516562INNOVA9, 516663INNOVA1A, 530244XC106, 561548CL4, 570476INNOVA31, 573458CL1, 573632CRC2, 6012883100CV2, 603421PCL, 610595CL1, 610770INNOVA31, 610983INNOVA1, 616392INNOVA, 617732IN9, 618241GSI3100, 620225INNOVA31, 631968INNOVA2, 631968INNOVA3, 662377CV2, 671GMHAINVA, 708WESTSUB3100, 713359INC,  713948INA, 717782INNOVA31A, 718245UNITY, 718470INNOVA2, 718780CATH2, 732776CATH6, 770991CL1, 772LWCL1, 775982CATH2, 781340IN2, 803255CL1, 804285CATH1, 814676C1,  815344CARDIAC3, 815756KCHSPEC, 816478MC1, 816861KCVAI1, 816943STJIC1, 816985NKCI, 847362CONCATH4, 856596IN3100, 864255SFCL3, 901516R3, 903UT3100, 904276CTH1, 909464IN3, 909825VAINNOVA, 910343NHIN4, 913345MI1, 940626DCH3100, 954987CCL9, 956698INN31, 970350CL1, 970945CL1, 973877LAB4, ECXV1406B, FHORLCL7, 580548B3100, 941798CLAB2, 760323DRINNOVA, 718270INNOVA1, 603580ECL1, MARTINSVILLE310, 480728LAB2, 865481CCL2, 405610NW3100, 8157413100, 251633PROV, 907562CATH1, 919784REP1, 601883CL1, 650369SV3, 610954INNOVA1, 760242CATH2, 314768SMCL1A, 2035763100A, 402559UCB, 561694IN1, 2036883100, 201996LAB1, 205877CCL2, 207351YCL1, 251435ICV6, 281420LAB1, 314525STACL2, 334418CL, 412623LAB2, 479441SP3100, 480821IN2, 508856IN2,  541MWHINNOVA, 573882UMC1, 610447CL1, 610526LAB1, 610526LAB2, 610891CL1, 617789IN1, 631376EP, 704384CATH2, 706481CCL, 706774CCL4, 706774CCL5, 713776M3100, 717782INNOVA31, 803256PCL1, 812450CATH1, 815226INN2, 863687CL31, 916781INNOVA1, 918494IN31A, 952993INNOVA5, BPINNOVA1, 845365V19, 918333JPIN1, 909788INNOVA1, 516663INNOVA2, 2652143 MARTINSVILLE310, 8185023100, 312STMNAZ3100, 630312B31,  717782INNOVA31B, 727725CATH2, 785354S3100,  918333JPIN2,  812450EP1, 316268INNOVAA, 717217INN31, 310825INNOVA31, 413540IN1,  615222HX, 850747GC3100, 516632INNOVA2, 314768SMCL3, "617789WS1, 617789IN1, "9734293100AW, 9734293100, "903UTAW31, 903UT3100", 870864LAB2, 815599FHN3100, 630856H31, 678957INNOVA, 0002676826X, 337374INNOVA, 727521CATHOP, 720225CL2, 678957INNOVA, 704355RM2, 609267IN3100, 9287883100, 541743CL6, 405636ISW3100, 575521CATHB, 9284533100, 443481EP, 504447INNOVA2, 931459CV1, 650723SC2, MCDCATH2, 732776CATH2, 812238LIB1, 313593IC1, 650938LY31, 609597IN3100, 853060194, 06074VAS01, 34115VAS02, 44009VAS01, 01012VAS01, 41018VAS01, 58002VAS01, 60001VAS01, 34268VAS01, SA1010VA02, RU3053VA01, RU1449VA01, RU1102VA02, RU1254VA01, 600098VA01, RU1482VA02, RU1475VA01, RU1142VA01, RU2581VA01, RU1457VA01, RU2741VA01, RU1692VA01, RU1001VA02, RU1913VA02, RU3136VA01, RU3137VA01, RU3135VA01, RU2886VA01, PL1650VA02, PL1688VA01, PL1681VA01, PL1640VA01, PL1082VA01, 600050VA02, PL1491VA01, 2048000INNOVA, 2664627INNOVA, 2685467INNOVA, 2716439INNOVA, 920169007, NO1005VA05, 834160003, 477XVIN2553211, 52XVINN2565367, 818INNOVAHM2, 0002714567B, LB1148VA01, LB1003VA01, KW1055VA01, 850060719, 850060724, 850060726, 850060727, 850060728, YV0165, YV0162, YV0048, YV0163, XF0250, YV0033, YV0034, YV0035, YV0038, YV0039, YV0040, YV0042, YV0043, YV0044, YV0045, YV0046, YV0047, YV0049, YV0050, YV0051, YV0023, YV0024, YV0025, YV0027, YV0028, YV0029, YV0030, YV0031, YV0032, YV0037,  YV0164,  YV0052,  YV0168,  YV0167,  JO1000VA01, A5718004, D5810520,  A5812258,  A5127281,  A5112597,  A5162256,  A5333035,  A5812244,  B5274834,  B5332001,  B5810907,  A5125119,  D5810520,  IQ1165VA01, IR1819VA01, HU1099VA04, H17654VAS9, H4672VAS02, GE1009VA01, GE1005VA01, GE1004VA01, 01243VAS03, 00203VAS01, 01367VAS02, 01243VAS03, M2030709, M4163030, M4166988,  M5480755, M6083613, A6017504, M2848425, M4016034, M40480151, A9190149, M40480167, FI1064VA01, MPX82206, FPG86403, FPG93008, DPM32143, DPN88402, FPA99414, 2655786INNOVA, HC4348XR01, CS1006VA03, 2625365INNOVA, 2645993INNOVA, 2735407INNOVA, 82416220009, 82416190004, "82449120026, 082416120007, 82416160012, 82416210009, 82416130027, 82416040018, 82416140004, 82416290001, 82416140003, 82416130018, 82416080001, 82416010006, 82416020004, 82416020005, 82416030006, 82416040015, 82416040019, 82416100013, 82416110002, 82416110003, 82416120010, 82416140002, 82416150001, 82416160008, 82416160009, 82416160013, 82416180004, 82416190004, 82416190001, 82416190002, 82416190003, 82416210006, 82416210008, 82416220008, 82416270002, 82416300001, 82416310003, 82416310006, 82449100050, 82416160011, 82416170002, 82416030003, 82416030008, 82416030010, 82416100006, 82416100010, 82416100019, 82416120007, 82416120011, 82416130015, 82416160003, 82416160006, 82416210003, 82416210004, 82416310007, 82416220009, 82416130017, 82416030009, 82416120012, 82416180005, 82416310008, 82416040017, "82449030045,  (082416030006)", 82416150003, 82416130028, 82416150003, 82416150003, 82416130028, 82416130018, BE5003VA02 (BY4015VA02), BY4066VA01, 2722671, 2722497, 2573329, 2676587, BG4549VA02, 140024RX09, BA4080VA01, 910064009, 910163012, 910163013, 910163015, 910064007, 910064008, 910162006, 910162008, 910163006, 910163007, 910163009, 378INV31, 4127INV31, TT-2586581-CO, 818INNOVAHM1, YV0167 and 82416290002 and;  Serial 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and 0000007C203516.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including Puerto Rico and states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY,NC, ND, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,WV and WI and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GEORGIA, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SPAIN, SUDAN, SOUTH AFRICA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, VENEZUELA and SOUTH AFRICA.
  • Product Description
    GE Innova 3100 / 3100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. || The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

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Device Recall Digital Fluoroscopic Imaging System
  • Model / Serial
    00000536885BU7 00000524151BU8 00000807/61010 123100037 1203100026 1203100029 00000507807BU6 00000520244BU5 00000460530BU9 00000469400bu6 00000452842BU8 00000112420VE5 00000469349BU5 00000469380BU0 00000307/50876 00000524122BU9 00000453185BU1 00000460590BU3 00000105/30212 9110080 00000469377BU6 00000504/10092 00000704/20116 00000507774BU8 00000493795BU9 00000307/50891 00000507773BU0 00000460632BU3 00000112399VE1 00000407/50915 00000483688BU8 704120117 00000536842BU8 00000112423VE9 00001004-20153 00000524162BU5 00000536835BU2 00000048698BU7 00000507811BU8 00000807/61019 00000507/50956 00001204/30190 00000507817BU5 00000469368BU5 00001204/30187 00000452891BU5 00000452866BU7 00000707/60982 00001204/30191 00000493809BU8 00000112407VE2 00000112409VE8 00000499188BU1 00000499133BU7 00000507792BU0 00000536845BU1 00000469343BU8 00000524118BU7 00000536848BU5 00000460550BU7 00000524167BU4 00000469355BU2 00000483704BU3 00000520268BU4 00000307/50878 00000407/50910 00000469359BU4 00000112427VE0 00000469354BU5 00000493804BU9 00000604-10104 00000507814BU2 00000453182BU8 00000307/50883 00000460580BU4 00000453184BU4 0000M04/200013 304110059 00000707/60979 00000507770BU6 00000499138BU6 00000307/50900 00000483685BU4 00000520280BU9 00000499152BU7 00000460557BU2 00000469410NU5 00000307/50872 00000536892BU3 00000112414VE8 00000460621BU6 00000520265BU0 00000524152BU6 00000807/61020 00000204/10054 00000499175BU8 00000466696BU2 00000493796BU7 00000507791BU2 00000499157BU6 00000524156BU7 00000536910BU3 00000524153BU4 00000507804BU3 1204930184 00000907/60185 00001004/20148 00000469352BU9 000000M0420A3A 00000306/40566 00000499153BU5 00000453180BU2 00000520271BU8 00000466723BU4 00000105/30152 00000904/20011 00001004/20143 00000507/50940 00000704/20106 00000536855BU0 00000536856BU8 00000452884BU0 00000520239BU5 00001104/20029 00000466690BU5 304110067 00000452853BU5 00000453191BU9 00000469329BU7 00000460626BU5 00000536830BU3 00000499132BU9 00000460602BU6 00000112417VE1 00000704/10107 00000507809BU2 00000452846BU9 00000107/50809 00000536851BU9 00000112425VE4 00000466712BU7 00001005/40426 00000460610BU9 00000112432VE0 00000307/50905 00000520296BU5 00000469347BU9 00000460603BU4 00000507/50935 00000452850BU1 00000307/50893 1203100022 00000536901BU2 00000407/50913 00000452857BU6 00000460559BU8 00000112433VE8 00000536849BU3 00000107/50819 00000536905BU3 00000807/61013 00000105/30213 00000520246BU0 00000520301BU3 00000460614BU1 00000105/30204 00000904/20136 00000507810BU0 00001003/00013 00000507802BU7 00000452887BU3 00000407/50168 00000907/61025 00001007/61036 00000520249BU4 00000452852BU7 00000707/60174 00001107/61043 00001107/61049 00000520275BU9 00001207/61086 00000453189BU3 00000807/61016 00001007/61031 00000108/61111 00001207/61083 00000452825BU3 00000108/61108 00000304/10062 00001007/61041 00000460587BU9 00000460571BU3 00000807/61021 00000452858BU4 00000807/61023 00000704/20104 00001207/61089 00000536890BU7 00000904/20139 00000520282BU5 00000469361BU0 00000707/60977 00000507803BU5 00000483703BU5 00000520288BU2 00000460624BU0 00000407/50912 00000469395BU8 00000307/50903 00000404/10085 00000507779BU7 00000499155BU0 00000469300BU8 00001104/20156 00000460599BU4 00000407/50920 00000452893BU1 00000307/50865 00000520235BU3 00000469239BU8 00000469247BU1 00000469416BU2 00000499170BU9 00000607/50964 00000466689BU7 00000466758BU0 00000507828BU2 00000469235BU6 00000536920BU2 00000607/50969 00000469293BU5 00000469277BU8 00000460517BU6 00000466715BU0 00000452822BU0 00000469242BU2 00000466732BU5 00000466698BU8 00000469318BU0 00000105/30153 00000807/60626 00000707/50607 00000466694BU7 00000469286BU9 00000407/50589 00000507829BU0 00000453151BU3 00000407/50592 00000469249BU7 00000407/50597 00000469260BU4 00000466725BU9 00000452833BU7 00000452820BU4 00000507831BU6 00000466729BU1 00000466708BU5 00000499163BU4 00000607/50606 00000536908BU7 00000453137BU2 00000807/60625 00000453157BU0 00000507808BU4 00000460565BU5 00000466720BU0 00000904/20133 00000469419BU6 00000536853BU5 00000507782BU1 00000460547BU3 00000507790BU4 00000460574BU7 00000112411VE4  00000407/50919 00000507/50958 00000524149BU2 00000907/61026 00000112442VE9 00000407/50166 00000108/61118 00000460548BU1 00000536919BU4 00000707/60997 00000707/50973 00000520260BU1 00000453143BU0 00000469301BU6 00000507785BU4 00000469255BU4 00000453147BU1 00000460541BU6 00000524126BU0 00000507/50960 00000493806BU4 00000499139BU4 00000453215BU6 00000507/50942 00000453171BU1 00000520297BU3 00000483690BU4 00000536841BU0 00000469254BU7 00000453209BU9 00000452911BU1 00000466759BU8 00000520236BU1 00000536879BU0 00000452881BU6 00001107/61056 00000112451VE0 00000524142BU7 00000307/50867 00000507/50933 00000507/50949 00000469376BU8 00000604/10089 00000520256BU9 00000469374BU3 00000407/50917 00000507/50934 00000507/50955 00000520284BU1 00000469229BU9 00000452802BU2 00000466692BU1 00000466726BU7 00000707/50612 00000407/50593 00000536893BU1 00000466722BU6 00000460529BU1 00000469319BU8 00000304/20127 00000499137BU8 00000524132BU8 00000407/50588 00000469270BU3 00000507/50945 and 00000507/50946
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • Product Description
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
    GE Healthcare
Device Recall Digital Fluoroscopic Imaging System
  • Model / Serial
    00000466713BU5 00000466705BU1 00000524119BU5 00000536916BU0 00000112428VE8 00000460509BU3 00000507823BU3 00000460516BU8 00000469271BU1 00000460505BU1 00000460528BU3 00000466687BU1 00000536866BU7 00000405/40253 00000466707BU7 00000307/50880 00000520248BU6 00000460549BU9 00000307/50896 00000469345BU3 00000112416VE3 00000466740BU8 00000460554BU9 00000469342BU0 00000466739BU0 00000466743BU2 00000466677BU2 00000460504BU4 00000466762BU2 00000307/50866 00000460623BU2 00000407/50914 00000536903BU8 00000707/60983 00000507796BU1 00000524158BU3 00000469363BU6 00000520259BU3 00000536827BU9 00000707/60999 00000466754BU9 00000493790BU0 00000520267BU6 00000112421VE3 00000493801BU5 00000407/50170 00000469344BU6 00000452845BU1 00000112418VE9 00000469335BU4 00000112431VE2 00000807/61017 00000469351BU1 00000460631BU5 00000469312BU3 00000452829BU5 00000520264BU3 00000536837BU8 00000605/00051 00000460609BU1 00000520276BU7 00000112419VE7 00000469370BU1 00000469358BU6 00000493805BU6 00000524117BU9 00000460520BU0 00000466675BU6 00000460511BU9 00000483699BU5 00000536839BU4 00000460615BU8 00000469328BU9 00000207-50843 00000466751BU5 00000469263BU8 00000507/50938 00000524147BU6 00000452812BU1 00000460569BU7 00000452921BU0 00000453224BU8 00000466767BU1 00000460503BU6 00000206/40463 00000524124BU5 00000460597BU8 00000407/50916 40372 00000452901BU2 404110077 00000466684BU8 00000536876BU6 00000536850BU1 00000536913BU7 00000466756BU4 00000469269BU5 00000507813BU4 00000112405VE6 00000112410VE6 00000460576BU2 00000466685BU5 00000466714BU3 00000466671BU5 00000536836BU0 00000108/60209 00000108/61090 00000707/60992 00000452836BU0 00001207/61063 00000907/60631 00000460585BU3 00000460563BU0 00000536904BU6 00000536922BU8 00000469372BU7 00000112447VE8 00000207/50856 00000460562BU2 00000520294BU0 00000707/60614 00000466674BU9 00000452840BU2 00000466734BU1 00000469299BU2 00000452826BU1 00000466700BU2 00000460532BU5 00000452841BU0 00000112452VE8 00000469302BU4 00000469244BU8 00000453158BU8 00000466735BU8 00000469224BU0 00000469282BU8 00000112400VE7 00000607/50602 00000469297BU6 00000466717BU6 00000524113BU8 00000507/50957 00000452927BU7 00000112436VE1 00001007/61039 00001007/61038 00000493808BU0 00000460510BU1 00000469272BU9 00000466681BU4 00000469288BU5 00000807/50176 00000520293BU2 00000469289BU3 00000469294BU3 00000469256BU2 00000469275BU2 00000460589BU5 00000536838BU6 00000460538BU2 00000466752BU3 00000307/50881 00000520274BU2 00000507/50950 00000520257BU7 00000524135BU1 00000507781BU3 00000507775BU5 00000536865BU9 00000707/50970 00000524161BU7 00000507797BU9 00000507784BU7 00000469401BU4 00000450567BU1 00000524143BU5 00001107/61052 00000469245BU5 00000806/00082 00000907/00156 00000460540BU8 00000460531BU7 00000460605BU9 00000112449VE4 00000607/50967 00000466730BU9 00000460526BU7 00000507/50922 00000469375BU0 00000460542BU4 00000469325BU5 00000499146BU9 00000499147BU7 00000520292BU4 00000469238BU0 00000460553BU1 00000469257BU0 00000520298BU1 00001107/61050 00000469259BU6 00000520258BU5 00000466747BU3 00000493803BU1 00000536891BU5 00000907/60637 00001107/60657 00000469399BU0 00000407/50586 00000407/50590 00000407/50596 00000469276BU0 00000507837BU3 00000469248BU9 00000507830BU8 00001207/60664 00000507838BU1 00000407/50165 00000520270BU0 00000469261BU2 00000507788BU8 00000707/50610 00000536923BU6 00000466742BU4 00000536854BU3 00000469290BU1 00000524150BU0 00000469281BU0 00000469258BU8 00000499178BU2 00000507772BU2 00000483696BU1 00000452934BU3 00000493794BU2 00000499180BU8 00000536832BU9 00000452914BU5 00000452908BU7 00000407/50164 00000483691BU2 00000452900BU4 00000807/60183 00000112456VE9 00000469333BU9 00000469387BU5 00000499154BU3 00000707/60980 00000469307BU3 00000466697BU0 00000469233BU1 00000524133BU6 00000112446VE0 00000707/50609 00000466731BU7 00000466718BU4 00000307/50882 00000460620BU8 00000469396BU6 00000524172BU4 00000469386BU7 00000524171BU6 00000507836BU5 00000707/60984 00000707/60617 00000469324BU8 00000707/50976 00000452831BU1 00000520240BU3 00000307/50889 00000469284BU4 00000520253BU6 00000607/50604 00000507839BU9 00000507/50952 00000469360BU2 and 00000307/50909
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • Product Description
    GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
    GE Healthcare
Device Recall Digital Fluoroscopic Imaging System
  • Model / Serial
    00000469348BU7 00000536877BU4 404110063 00000452883BU2 00000504/10096 00000460596BU0 00000469365BU1 00000704/20115 704120114 00000536912BU9 00000460572BU1 00000052416BU0 00000460630BU7 00000307/50895 120310008 00001104/20158 00000507/50928 00000460594BU5 00000452882BU4 00000453177BU8 00000461253BU7 00000307/50879 20116 00001004/20116 00000307/50884 1003100012 00000536843BU6 00000469338BU8 00000112413VE0 50410084 00000452854BU3 00000453150BU5 00000453167BU9 00000524168BU2 904120023 00000452892BU3 00000112412VE2 00000524121BU1 00000469322BU2 00000112461VE9 00000507/50921 00000507767BU2 00000469371BU9 00000112408VE0 00000905/40399 00000453140BU6 00000907/61022 00001003/00003 00000469364BU4 1203100039 00000452885BU7 00000469346BU1 404110064 00000452862BU6 00000507812BU6 00000499183BU2 00000499131BU1 00000483701BU9 00000452873BU3 1203100032 00000466706BU9 0000066706BU94 00000452871BU7 00000536900BU4 00000112403EV1 00000112403VE1 1203100034 1003 00000453165BU3 00000469337BU0 404110079 00000469264BU6 00000466763BU0 00000520277BU5 110310015 00000469330BU5 00000524129BU4 00001004/20145 00000404/10086 104100047 304110017 00000GD60U6-GE 00000904/20130 00000453213BU1 00000469394BU1 1103100020 00000461251BU1 1203100033 110420162 00000469367BU7 00000466688BU9 00000469381BU8 00000469350BU3 00000460560BU6 504110085 00000112397VE5 00000307/50868 00000507832BU4 00000307/50877 00000452828BU7 00000524154BU2 00000GD60U4-GE 00000469407BU1 904 00000524163BU3 00000460611BU7 00000466709BU3 00000460579BU6 00000104/00046 00000461252BU9 00000460568BU9 0000CA04110576 00000112434VE6 00000466755BU6 00000704/20106 00000520281BU7 00000499151BU9 00000469227BU3 00000469240BU6 00000460591BU1 00000104/00042 1204130176 00000499150BU1 00000507805BU0 00000452848BU5 604120099 00000307/50886 00000105/30203 00000105/32203 00000452880BU8 00000907/60635 1204130198 00000307/50885 00000469310BU7 00000804/20123 00001003/00007 1003100004 00000507815BU9 00000493792BU6 00000105/30201 00000460570BU5 00000507/50937 00000707/60995 00000461250BU3 00000524155BU9 00000507771BU4 00000524137BU7 00000452861BU8 00000507818BU3 00000104/00048 00000404/10074 00001204/30196 00000112398VE3 00000520251BU0 00000520278BU3 00001207/61080 00000507766BU4 00000805/40266 00000469317BU2 00000404/16671 00001207/61071 00000108/61116 00001207/60662 00001207/61067 00001104/20129 00000807/61014 00000108/61106 00000524114BU6 00000452811BU3 00001207/61087 00001007/61035 00001207/61064 00000460601BU8 00001207/60196 00001207/61081 00000453211BU5 00000469273BU7 00000108/61099 00000460577BU0 00000466745BU7 00000404/10066 00000707/60981 00000452879BU0 00000707/61001 00000453170BU3 00001004/20119 00001007/61034 00000108/61095 00000707/60988 00000707/61000 00001004/20146 00000460618BU2 00001207/60200 00000536872BU5 00000507/50931 00000507/50932 00000520299BU9 00001206/30188 00000507793BU8 00001104/20170 00000307/50888 00000536917BU8 00000524164BU1 00000452800BU6 00000507827BU4 00000469305BU7 00000520242BU9 00000507/50951 304110070 00000536832BU1 00000469393BU3 00001203/00034 00000112438VE7 00001203/00030 00000460566BU3 00000604/20097 00000469379BU2 00000507/50954 00000807/60622 00000807/61006 00000453135BU6 00000507/50953 00000407/50587 00000469391BU7 00000460575BU4 00000707/50975 00001104/20134 00000499165BU9 00000469241BU4 00000469253BU9 00000466761BU4 00000499189BU9 00000469331BU3 1204130137 00000499142BU8 00000108/60208 00000112454VE4 00000493796BU3 00000112401VE5 00000407/50918 00000469339BU6 00000507824BU1 00000452803BU0 00000507/50930 00000208/61132 00000404/10074 00000466703BU6 00000524130BU2 00000524160BU9 00001107/61060 00000507799BU5 and 00000807/60623
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • Product Description
    GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
    GE Healthcare
Device Recall Digital Fluoroscopic Imaging System
  • Model / Serial
    00001104/20163 00000453208BU1 00000604/20009 00000452923BU6 00001104/20026 1003000011 106100046 304110016 00000483694BU6 1103100017 00000483695BU3 00001004/20125 00000452904BU6 00000905/40049 50410007 00000904/20132 00000904/20010 00001103/20127 00000404/10003 00000466738BU2 1203100011 00000453217BU2 00001103/00006 00000045295BU1 1203100009 120340010 00000461244BU6 00000499182BU4 00000453148BU9 00000460515BU0 00000461241BU2 00001204/30194 00000453153BU9 00000705/40244 00000452906B01 00000452906BU1 00000453194BU3 00000453146BU3 00000604/20019 00000466737BU4 00001107/61054 00000453132BU3 00000453154BU7 00000453156BU2 00000453161BU2 00000469231BU5 00000452821BU2 00000461245BU3 00000112406VE4 00000461242BU0 00000453152BU1 00000461246BU1 00000461247BU9 00000461243BU8 00001107/00019 00000469389BU1 00000452835BU2 00000466670BU7 00000469265BU3 00000466721BU8 00000453149BU7 and 00000453216BU4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • Product Description
    Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.
  • Manufacturer
    GE Healthcare
Device Recall Digital Fluoroscopic Imaging System
  • Model / Serial
    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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • Product Description
    Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment.
  • Manufacturer
    GE Healthcare
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