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 number

Z-1475-2009

Recalling firm

GE Medical Systems, LLC

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.

Status

Terminated

Initiated

2008-06-17

Posted

2009-06-19

Terminated

2014-10-22

Reason

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.

Root cause

Process control

Action

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.

Quantity

524 plus 11 either 3100 or 4100

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.

Lot, serial or model codes

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.

510(k) numbers

["K031637","K042053","K052157","K052412","K061163"]

PMA numbers

not on file

Product code

MQB

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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