GE Medical Systems, LLC 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. Recall
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Product
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.
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
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 Numbers: 00000444288BU5, 00000007C20379, 00000007C20365, 00000007C20117, 00000007C20224, 00000007C20340, 00000007C20398, 00000007C20322, 00000007C20335, 00000007C20313, 00000007C20270, 00000007C20297, 00000007C20344, 00000007C20250, 00000007C20299, 00000007C20374, 00000007C20300, 00000519174BU7, 00000464119BU7, 00000007C20073, 00000498700BU4, 00000464046BU2, 00000489762BU5, 00000489716BU1, 00000007C20009, 00000007C20013, 00000499941BU3, 00000465048BU7, 00000498877BU0, 00000536805BU5, 00000498690BU7, 00000007C20055, 00000464124BU7, 00000464128BU8, 00000007C20049, 00000453941BU7, 00000464042BU1, 00000489765BU8, 00000007C20005, 00000491059BU2, 00000519142BU4, 00000007C20012, 00000464079BU3, 00000520055BU5, 00000464063BU7, 00000519156BU4, 00000007C20033, 00000489690BU8, 00000477766BU0, 00000444301BU6, 00000007C20076, 00000489776BU5, 00000532662BU4, 00000464120BU5, 00000477743BU9, 00000498882BU0, 00000513252BU7, 00000498702BU0, 00000464088BU4, 00000007C20017, 00000464094BU2, 00000464112BU2, 00002UA6251HCZ, 00000464133BU8, 00000453950BU8, 00000477758BU7, 00000489773BU2, 00000498695BU6, 00000007C20022, 00000513193BU3, 00000519147BU3, 00000007C20034, 00000536782BU6, 00000519164BU6, 00000444295BU0, 00000536783BU4, 00000536780BU0, 00000007C20031, 00000007C20004, 00000519124BU2, 00000489715BU3, 00000007C20039, 00000536797BU4, 00000477816BU3, 00000464136BU1, 00000477840BU3, 00000509236BU6, 00000519184BU6, 00000489714BU6, 00000519128BU3, 00000498707BU9, 00000464066BU0, 00000519162BU2, 00000498891BU1, 00000512755BU5, 00000520053BU0, 00000513267BU5, 00000499961BU1, 00000489771BU6, 00000498876BU2, 00000464127BU0, 00000464100BU7, 00000487475BU6, 00000489767BU4, 00000007C20078, 00000007C20027, 00000520038BU1, 00000477789BU2, 00000520042BU3, 00000519141BU6, 00000489717BU9, 00000498878BU8, 00000499702BU9, 00000479625BU6, 00000536803BU0, 00000491228BU3, 00000498687BU3, 00000477748BU8, 00000519118BU4, 00000464118BU9, 00000520085BU2, 00000513536BU3, 00000489712BU0, 00000520043BU1, 00000498692BU3, 00000498659BU2, 00000477775BU1, 00000477827BU0, 00000007C20068, 00000520066BU2, 00000519177BU0, 00000007C20060, 00000498890BU3, 00000493965BU8, 00000538734BU5, 00000538740BU2, 00000513172BU7, 00000534470BU0, 00000477765BU2, 00000510040BU9, 00000519102BU8, 00000077902VE5, 00000498684BU0, 00000477779BU3, 00000519093BU9, 00000520040BU7, 00000536792BU5, 00000453928BU4, 00000519112BU7, 00000007C20054, 00000464050BU4, 00000519110BU1, 00000464135BU3, 00000477825BU4, 00000489758BU3, 00000513236BU0, 00000519090BU5, 00000489774BU0, 00000498704BU6, 00000453936BU7, 00000477808BU0, 00000477793BU4, 00000536788BU3, 00000464096BU7, 00000477768BU6, 00000479577BU9, 00000469847BU8, 00000453952BU4, 00000489748BU4, 00000489725BU2, 00000519160BU6, 00000520064BU7, 00000007C20125, 00000007C20167, 00000007C20165, 00000007C20098, 00000007C20083, 00000007C20154, 00000477746BU2, 00000466983BU4, 00000007C20141, 00000499889BU4, 00000498879BU6, 00000477812BU2, 00000007C20187, 00000007C20120, 00000007C20112, 00000007C20110, 00000007C20179, 00000007C20131, 00000007C20159, 00000536814BU7, 00000007C20072, 00000007C20161, 00000435348BU8, 00000007C20087, 00000444238BU0, 00000007C20198, 00000093711VE0, 00000007C20216, 00000007C20211, 00000434779BU5, 00000444290BU1, 00000510195BU1, 00000418661BU5, 00000098242VE1, 00000434369BU5, 00000453915BU1, 00000007C20197, 00000007C20272, 00000457662BU5, 00000479481BU4, 00000007C20209, 00000007C20252, 00000007C20234, 00000444323BU0, 00000444267BU9, 00000427535BU0, 00000526279BU5, 000000MI001346, 00000444246BU3, 00000098246VE2, 00000007C20199, 00000467359BU6, 00000453922BU7, 00000444332BU1, 00000098245VE4, 00000453923BU5, 00000444300BU8, 00000098190VE2, 00000441966BU9, 00000007C20154, 00000007C20275, 00000539156BU0, 00000007C20058, 00000007C20296, 00000007C20332, 00000007C20212, 00000007C20334, 00000464054BU6, 00000444280BU2, 00000464102BU3, 00000536804BU8, 00000444242BU2, 00000007C20303, 00000007C20327, 00000441175BU7, 00000479481BU4, 00000498882BU0, 00000498704BU6, 00000435903BU0, 00000434965BU0, 00000007C20258, 00000007C20352, 00000007C20227, 00000007C20253, 00000007C20258, 00000007C20290, 00000007C20293, 00000007C20331, 00000007C20351, 00000007C20358, 00000007C20373, 00000007C20383, 00000007C20384, 00000007C20387, 00000007C20396, 00000007C20397, 00000007C20399, 00000008C20040, 000000MI003748, 00000444269BU5, 00000007C20237, 00000008C20056, 00000464040BU5, 00000007C20132, 00000536815BU4, 00000520046BU4, 00000505109BU9, 00000520077BU9, 00000519143BU2, 00000007C20151, 00000093727VE6, 00000007C20181, 00000477828BU8, 00000464060BU3, 00000007C20024, 00000464039BU7, 00000477752BU0, 00000536789BU1, 00000464086BU8, 00000499933BU0, 00000007C20067, 00000007C20175, 00000519113BU5, 00000007C20215, 00000007C20261, 00000007C20263, 00000007C20298, 00000007C20346, 00000007C20382, 00000007C20307, 00000007C20343, 00000519167BU1, 00000007C20090, 00000477772BU8, 00000536800BU6, 00000008C20037, 00000444321BU4, 00000519126BU7, 00000007C20030, 00000007C20279, 00000519107BU7, 00000434370BU3, 00000497494BU5, 00000441211BU0, 00000444282BU8, 00000007C20319, 00000007C20105, 00000007C20109, 00000007C20088, 00000007C20050, 00000512702BU2, 00000489707BU0, 00000498672BU5, 00000520076BU1, 00000007C20065, 00000007C20225, 00000007C20135, 00000007C20015, 00000007C20173, 00000477866BU8, 00000513287BU3, 00000464108BU0, 00000464097BU5, 00000511691BU8, 00000477755BU3, 00000477787BU6, 00000477791BU8, 00000513175BU0, 00000477830BU4, 00000477834BU6, 00000498703BU8, 00000520073BU8, 00000007C20144, 00000519187BU9, 00000007C20059, 00000512703BU0, 00000099707VE2, 00000099789VE0, 00000450659BU8, 00000444299BU2, 00000453904BU5, 00000444331BU3, 00000464067BU8, 0000453944BU1, 00000464110BU6, 00000007C20266, 00000007C20203, 00000008C20048, 00000008C20057, 00000509188BU9, 00000007C20230, 00000007C20377, 00000007C20338, 00000464106BU4, 00000498681BU6, 00000007C20057, 00000526236BU5, 00000498697BU2, 00000489741BU9, 00000519185BU3, 00000489779BU9, 00000444313BU1, 00000007C20377, 00000532660BU8, 00000519122BU6, 00000498693BU1, 00000007C20325, 00000007C20185, 00000007C20256, 00000509199BU6, 00000520057BU1, 00000007C20390, 00000007C20096, 00000007C20116, 00000007C20390, 00000491248BU1, 00000464071BU0, 00000498674BU1, 00000498147BU8, 00000519153BU1, 00000007C20206, 00000444311BU5, 00000444263BU8, 00000438631BU4, 00000007C20304, 00000007C20311, 00000453943BU3, 00000519183BU8, 00000453924BU3, 00000499711BU0, 00000498682BU4, 00000498676BU6, 00000410867BU6, 00000520061BU3, 00000489750BU0, 00000441166BU6, 00000477833BU8, 00000489764BU1, 00000007C20395, 00000464070BU2, 00000513184BU2, 00000444310BU7, 00000519145BU7, 00000007C20242, 00000007C20202, 00000498886BU1, 00000007C20042, 00000519188BU7, 00000464089BU2, 000000MI002722, 00000464085BU0, 00000513189BU1, 00000511704BU9, 00000536798BU2, 00000498666BU7, 00000513529BU8, 00000489710BU4, 00000489708BU8, 00000489703BU9, 00000477823BU9, 00000464082BU7, 00000511694BU2, 00000453947BU4, 00000477794BU2, 00000477836BU1, 00000007C20045, 00000536793BU3, 00000513184BU2, 00000453914BU4, 00000511627BU2, 00000499695BU5, 00000464059BU5, 00000489732BU8, 00000464073BU6, 00000459701BU9, 00000513183BU4, 00000479561BU3, 00000477839BU5, 00000513182BU6, 00000519116BU8, 00000520082BU9, 00000479483BU0, 00000007C20011, 00000007C20177, 00000505115BU6, 00000453933BU4, 00000007C20080, 00000444310BU7, 00000007C20147, 00000444250BU5, 00000445632BU3, 00000441205BU2, 00000099664VE5, 00000453920BU1, 00000007C20026, 00000464070BU2, 00000467629BU2, 00000007C20145, 00000007C20257, 00000007C20155, 00000007C20129, 00000477777BU7, 00000498666BU7, 00000007C20381, 00000007C20254, 00000007C20381, 00000007C20381, 00000007C20254, 000000MI002722, 00000498706BU1, 00000007C20385, 00000007C20368, 00000008C20022, 00000513573BU6, 00000536812BU1, 00000007C20066, 00000007C20082, 00000519152BU3, 00000498888BU7, 00000499707BU8, 00000477807BU2, 00000519148BU1, 00000511646BU2, 00000441198BU9, 00000441200BU3, 00000444255BU4, 00000500006BU2, 00000444270BU3, 000000000ATLAS, 00000510179BU5, 00000007C20372, 00000469103BU6, 00000007C20354, 00000008C20057, 00000007C20238, 000000MI003340, 000000MI003749, 00000514117BU1, 00000514127BU0, 00000007C20284, 00000007C20295, 00000007C20317, 00000007C20318, 00000007C20371, 00000007C20391, 00000007C20402 and 0000007C203516.
Products Sold
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 Numbers: 00000444288BU5, 00000007C20379, 00000007C20365, 00000007C20117, 00000007C20224, 00000007C20340, 00000007C20398, 00000007C20322, 00000007C20335, 00000007C20313, 00000007C20270, 00000007C20297, 00000007C20344, 00000007C20250, 00000007C20299, 00000007C20374, 00000007C20300, 00000519174BU7, 00000464119BU7, 00000007C20073, 00000498700BU4, 00000464046BU2, 00000489762BU5, 00000489716BU1, 00000007C20009, 00000007C20013, 00000499941BU3, 00000465048BU7, 00000498877BU0, 00000536805BU5, 00000498690BU7, 00000007C20055, 00000464124BU7, 00000464128BU8, 00000007C20049, 00000453941BU7, 00000464042BU1, 00000489765BU8, 00000007C20005, 00000491059BU2, 00000519142BU4, 00000007C20012, 00000464079BU3, 00000520055BU5, 00000464063BU7, 00000519156BU4, 00000007C20033, 00000489690BU8, 00000477766BU0, 00000444301BU6, 00000007C20076, 00000489776BU5, 00000532662BU4, 00000464120BU5, 00000477743BU9, 00000498882BU0, 00000513252BU7, 00000498702BU0, 00000464088BU4, 00000007C20017, 00000464094BU2, 00000464112BU2, 00002UA6251HCZ, 00000464133BU8, 00000453950BU8, 00000477758BU7, 00000489773BU2, 00000498695BU6, 00000007C20022, 00000513193BU3, 00000519147BU3, 00000007C20034, 00000536782BU6, 00000519164BU6, 00000444295BU0, 00000536783BU4, 00000536780BU0, 00000007C20031, 00000007C20004, 00000519124BU2, 00000489715BU3, 00000007C20039, 00000536797BU4, 00000477816BU3, 00000464136BU1, 00000477840BU3, 00000509236BU6, 00000519184BU6, 00000489714BU6, 00000519128BU3, 00000498707BU9, 00000464066BU0, 00000519162BU2, 00000498891BU1, 00000512755BU5, 00000520053BU0, 00000513267BU5, 00000499961BU1, 00000489771BU6, 00000498876BU2, 00000464127BU0, 00000464100BU7, 00000487475BU6, 00000489767BU4, 00000007C20078, 00000007C20027, 00000520038BU1, 00000477789BU2, 00000520042BU3, 00000519141BU6, 00000489717BU9, 00000498878BU8, 00000499702BU9, 00000479625BU6, 00000536803BU0, 00000491228BU3, 00000498687BU3, 00000477748BU8, 00000519118BU4, 00000464118BU9, 00000520085BU2, 00000513536BU3, 00000489712BU0, 00000520043BU1, 00000498692BU3, 00000498659BU2, 00000477775BU1, 00000477827BU0, 00000007C20068, 00000520066BU2, 00000519177BU0, 00000007C20060, 00000498890BU3, 00000493965BU8, 00000538734BU5, 00000538740BU2, 00000513172BU7, 00000534470BU0, 00000477765BU2, 00000510040BU9, 00000519102BU8, 00000077902VE5, 00000498684BU0, 00000477779BU3, 00000519093BU9, 00000520040BU7, 00000536792BU5, 00000453928BU4, 00000519112BU7, 00000007C20054, 00000464050BU4, 00000519110BU1, 00000464135BU3, 00000477825BU4, 00000489758BU3, 00000513236BU0, 00000519090BU5, 00000489774BU0, 00000498704BU6, 00000453936BU7, 00000477808BU0, 00000477793BU4, 00000536788BU3, 00000464096BU7, 00000477768BU6, 00000479577BU9, 00000469847BU8, 00000453952BU4, 00000489748BU4, 00000489725BU2, 00000519160BU6, 00000520064BU7, 00000007C20125, 00000007C20167, 00000007C20165, 00000007C20098, 00000007C20083, 00000007C20154, 00000477746BU2, 00000466983BU4, 00000007C20141, 00000499889BU4, 00000498879BU6, 00000477812BU2, 00000007C20187, 00000007C20120, 00000007C20112, 00000007C20110, 00000007C20179, 00000007C20131, 00000007C20159, 00000536814BU7, 00000007C20072, 00000007C20161, 00000435348BU8, 00000007C20087, 00000444238BU0, 00000007C20198, 00000093711VE0, 00000007C20216, 00000007C20211, 00000434779BU5, 00000444290BU1, 00000510195BU1, 00000418661BU5, 00000098242VE1, 00000434369BU5, 00000453915BU1, 00000007C20197, 00000007C20272, 00000457662BU5, 00000479481BU4, 00000007C20209, 00000007C20252, 00000007C20234, 00000444323BU0, 00000444267BU9, 00000427535BU0, 00000526279BU5, 000000MI001346, 00000444246BU3, 00000098246VE2, 00000007C20199, 00000467359BU6, 00000453922BU7, 00000444332BU1, 00000098245VE4, 00000453923BU5, 00000444300BU8, 00000098190VE2, 00000441966BU9, 00000007C20154, 00000007C20275, 00000539156BU0, 00000007C20058, 00000007C20296, 00000007C20332, 00000007C20212, 00000007C20334, 00000464054BU6, 00000444280BU2, 00000464102BU3, 00000536804BU8, 00000444242BU2, 00000007C20303, 00000007C20327, 00000441175BU7, 00000479481BU4, 00000498882BU0, 00000498704BU6, 00000435903BU0, 00000434965BU0, 00000007C20258, 00000007C20352, 00000007C20227, 00000007C20253, 00000007C20258, 00000007C20290, 00000007C20293, 00000007C20331, 00000007C20351, 00000007C20358, 00000007C20373, 00000007C20383, 00000007C20384, 00000007C20387, 00000007C20396, 00000007C20397, 00000007C20399, 00000008C20040, 000000MI003748, 00000444269BU5, 00000007C20237, 00000008C20056, 00000464040BU5, 00000007C20132, 00000536815BU4, 00000520046BU4, 00000505109BU9, 00000520077BU9, 00000519143BU2, 00000007C20151, 00000093727VE6, 00000007C20181, 00000477828BU8, 00000464060BU3, 00000007C20024, 00000464039BU7, 00000477752BU0, 00000536789BU1, 00000464086BU8, 00000499933BU0, 00000007C20067, 00000007C20175, 00000519113BU5, 00000007C20215, 00000007C20261, 00000007C20263, 00000007C20298, 00000007C20346, 00000007C20382, 00000007C20307, 00000007C20343, 00000519167BU1, 00000007C20090, 00000477772BU8, 00000536800BU6, 00000008C20037, 00000444321BU4, 00000519126BU7, 00000007C20030, 00000007C20279, 00000519107BU7, 00000434370BU3, 00000497494BU5, 00000441211BU0, 00000444282BU8, 00000007C20319, 00000007C20105, 00000007C20109, 00000007C20088, 00000007C20050, 00000512702BU2, 00000489707BU0, 00000498672BU5, 00000520076BU1, 00000007C20065, 00000007C20225, 00000007C20135, 00000007C20015, 00000007C20173, 00000477866BU8, 00000513287BU3, 00000464108BU0, 00000464097BU5, 00000511691BU8, 00000477755BU3, 00000477787BU6, 00000477791BU8, 00000513175BU0, 00000477830BU4, 00000477834BU6, 00000498703BU8, 00000520073BU8, 00000007C20144, 00000519187BU9, 00000007C20059, 00000512703BU0, 00000099707VE2, 00000099789VE0, 00000450659BU8, 00000444299BU2, 00000453904BU5, 00000444331BU3, 00000464067BU8, 0000453944BU1, 00000464110BU6, 00000007C20266, 00000007C20203, 00000008C20048, 00000008C20057, 00000509188BU9, 00000007C20230, 00000007C20377, 00000007C20338, 00000464106BU4, 00000498681BU6, 00000007C20057, 00000526236BU5, 00000498697BU2, 00000489741BU9, 00000519185BU3, 00000489779BU9, 00000444313BU1, 00000007C20377, 00000532660BU8, 00000519122BU6, 00000498693BU1, 00000007C20325, 00000007C20185, 00000007C20256, 00000509199BU6, 00000520057BU1, 00000007C20390, 00000007C20096, 00000007C20116, 00000007C20390, 00000491248BU1, 00000464071BU0, 00000498674BU1, 00000498147BU8, 00000519153BU1, 00000007C20206, 00000444311BU5, 00000444263BU8, 00000438631BU4, 00000007C20304, 00000007C20311, 00000453943BU3, 00000519183BU8, 00000453924BU3, 00000499711BU0, 00000498682BU4, 00000498676BU6, 00000410867BU6, 00000520061BU3, 00000489750BU0, 00000441166BU6, 00000477833BU8, 00000489764BU1, 00000007C20395, 00000464070BU2, 00000513184BU2, 00000444310BU7, 00000519145BU7, 00000007C20242, 00000007C20202, 00000498886BU1, 00000007C20042, 00000519188BU7, 00000464089BU2, 000000MI002722, 00000464085BU0, 00000513189BU1, 00000511704BU9, 00000536798BU2, 00000498666BU7, 00000513529BU8, 00000489710BU4, 00000489708BU8, 00000489703BU9, 00000477823BU9, 00000464082BU7, 00000511694BU2, 00000453947BU4, 00000477794BU2, 00000477836BU1, 00000007C20045, 00000536793BU3, 00000513184BU2, 00000453914BU4, 00000511627BU2, 00000499695BU5, 00000464059BU5, 00000489732BU8, 00000464073BU6, 00000459701BU9, 00000513183BU4, 00000479561BU3, 00000477839BU5, 00000513182BU6, 00000519116BU8, 00000520082BU9, 00000479483BU0, 00000007C20011, 00000007C20177, 00000505115BU6, 00000453933BU4, 00000007C20080, 00000444310BU7, 00000007C20147, 00000444250BU5, 00000445632BU3, 00000441205BU2, 00000099664VE5, 00000453920BU1, 00000007C20026, 00000464070BU2, 00000467629BU2, 00000007C20145, 00000007C20257, 00000007C20155, 00000007C20129, 00000477777BU7, 00000498666BU7, 00000007C20381, 00000007C20254, 00000007C20381, 00000007C20381, 00000007C20254, 000000MI002722, 00000498706BU1, 00000007C20385, 00000007C20368, 00000008C20022, 00000513573BU6, 00000536812BU1, 00000007C20066, 00000007C20082, 00000519152BU3, 00000498888BU7, 00000499707BU8, 00000477807BU2, 00000519148BU1, 00000511646BU2, 00000441198BU9, 00000441200BU3, 00000444255BU4, 00000500006BU2, 00000444270BU3, 000000000ATLAS, 00000510179BU5, 00000007C20372, 00000469103BU6, 00000007C20354, 00000008C20057, 00000007C20238, 000000MI003340, 000000MI003749, 00000514117BU1, 00000514127BU0, 00000007C20284, 00000007C20295, 00000007C20317, 00000007C20318, 00000007C20371, 00000007C20391, 00000007C20402 and 0000007C203516.
GE Medical Systems, LLC is recalling GE Innova 3100 / 3100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. The prod due to GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during X-Ray imaging, the acquisition fails and the user has to rest the system. To date, one patient death has been reported related to this issue.
Recommended Action
Per FDA guidance
GE Healthcare sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Health Care Professionals describing the problem with the affected devices including instructions to avoid further problems until a GE Healthcare service representative is able to make contact and upgrade the system. Further questions may be addressed by calling 1-800-437-1171.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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, WI, PR
Page updated: Jan 10, 2026