GE Medical Systems, LLC GE Innova 2100 IQ Versatile Cardiac and Vascular 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 2100 IQ Versatile Cardiac and Vascular 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: ZA2239RX01, 857307IN421, 417347FCV2, 262687CL2, 409938INV21, 516632INNOVA1, 704384CL21, 505848CATH1, 505848EP, 318448INNOVA3, 305682IN2, 410554INNOVA2, 208367INNOVA, 208381CCL1, 2035762100, 717217CA10002 (717217INN21), 843797TCL1, 214947MINNOVA, 214947MINNOVA2, PRESBYDEP, 303839CL2, 252384CATH1, 303788CL1, 4436432100, 4107872100, 8184092100, 864255SFCL2, 219932DCL2, 305364P2100, 954987CL4, 713794LAB1, 727869CATH3, 727869CCL2, 727869EP5, 208227CATH1, 8157412100, 816861KCVAI2, 308865GIN1, 865693CCL, 865693CCL2, 608775NOVA2, 310825INNOVA21, 516562INNOVA6, 516562INNOVA7, 865977CCL, 217383CCL2A, 541732CV2, 251435ICV3, 239436CATH4, 732776CATH4, 212305CATH1, 212604INNOVA1, 65049321, 304424INNOVA, 610983INNOVA2, 201447LAB1, 215453INNOVA21, 253627INNOVA1, 229228INNOV21C, 8053702100, RPINNOVA2100, 303425CL3, 317355INNOVA3, 318448CA1000 (318448INNOVA3), 330363LAB3, 330375LAB2, 336538ARCL1, 360456XCL4, 405604D2100, 408559INV1, 410554INNOVA1, 414291CL2, 414649INNOVA2, 417269SCLA, 417347FCV4, 423495MCATH1, 501257VALAB1, 508856IN21, 509575YM2100, 516562INNOVA2A, 518243LAB1, 518243LAB2, 561548ET2, 570476INNOVA21, 573761SMC2, 573815BCR2, 573815BCR3, 573815BCR4, 574535IN21, 602239CLAB2, 607737CL1, 608775NOVA1, 610250INNOVA1, 610250INNOVA3, 610776INNOVA21, 612273INNOVA2, 615284CV3, 615342CV3, 615446CV1, 617636CL1, 630856H2100, 650369SV4, 651582IN3, 661327INNOVA1, 661327INNOVA2, 706291CLIN1, 713375U2100, 713375UCA, 717217INN21, 717544GECATH2, 717544GECATH3, 718470EP, 718780CATH3, 727942CATH2, 732324INN1, 732923INN, 770HMCCL1, 781340IN1, 781340IN3, 785354HRTEP, 803256PCL5, 808547QCV1A, 808547QCV3A, 812238UN21, 813615CL1, 813615CL8, 813615CL9, 813615EP3, 814452EP, 815759CARDIAC1, 817329BG2100, 843724CL1, 843724CL2, 843724CL3, 843724EP1, 845368LAB1, 845368LAB2, 856853IN2100, 858554INNOVA2, 858554INNOVA3, 864255SFCL1, 904597CATH, 910343EP1, 910343EP2, 910671INOV21, 916781INNOVA2, 937208INNOVA2, 954735CL2, 954987CCL7, 954987CCL8, 970350CL2, 9704CHINNOVA, 973579LAB1, 985898INNOVAA, 985898INNOVAB, CM2100, ECXV1406F, FHOMEP, 508941IN21, 508335INNOVA, 843692CATH3, 828213IN21, 901765EP, 410554INNOVA4, 410554INNOVA3, 251435ICV7, 262255INNOVA2, 303369HCL4, 410337INNOVA6, 573256MHC, 804764CATH2, 845365V13, 7023602100, 9284532100, 336832MCCL6, 402559UCD, 775982INN2100, 847316INNOVA1, 847316INNOVA2, LVINOV7, 0002651218X, 402559UCC, 4105502100XX, 0002507622X, 845368CATH1, 845368CATH2, 262687CL1, 336538ARCL, 619457INNOVA6, 949250I21, 630856H21EP, 202782LABC, 619457INNOVA5, 336538ARCL, 610988INNOVA5, 508422IN21, 630856H21EP, 303629EP2, 853060191, 853060197, 853060193, 853060195, 853060199, 853060199, 34097VAS01, 01031VAS01, 71004VAS01, 06052VAS01, 20001VAS02, 34009VAS06, 34134VAS02, 35049VAS01, 58010VAS01, 80002VAS01, 06004VAS03, 35021VAS02, 34097VAS01, 34280VAS01, SY1001VA02, SY2005VA01, SK1083VA01, SK1064VA01, SK1110VA01, SI4069VA01, 847160002, 847160003, A004RX01, A020RX13, SD1038VA01, SA1011VA01, SA1054VA02, PER00218, 787844INNOVACL1, 787844INNOVACL2, 787844INNOVACL3, PL1101VA03, 600151VA01, 600042VA03, PL1677VA01, 843160005, 2737019, 2752691, 920169006, NO1009VA03, NO1064VA03, 644INNOVA21, 83INNOVA2588441, 81INOVAISSSTE08, 36INOVA2733687, MA1004VA02, LV4000VA02, LV4000VA03, LV4001VA02, LT4000VA04, LB1042VA01, KW1018VA05, KW1018VA01, KW1018VA02, KW1018VA03, 850060723, 850060729, YV0054, YV0057, YV0058, YV0059, YV0060, YV0061, YV0062, YV0063, YV0064, YV0065, YV0066, YV0067, YV0068, YV0070, YV0071, YV0072, YV0073, YV0074, YV0075, YV0076, YV0077, YV0078, YV0079, YV0080, YV0081, YV0100, YV0055, YV0056, YX1483, YV0082, YV0083, YV0085, YV0088, YV0088, YV0086, YV0085, YV0090, D5810523, A5129022, A5333036, A5333037, A147111802, A5125125, A5129025, A5131858, A5155141, A5164510, A5219606, A5220710, A5286803, A5400910, A5605743, A5624112, A5800506, A5807919, A58080104, B5120723, C5123625, C5123626, C5323515, A5624127, A5697709, A5764002, B5603933, A5111034, D5810523, IR1748VA01, 8.30E+13, 2644132, 8.3016E+12, 083016002101586 (83016002101581), 8.30161E+13, 8.30162E+13, 8.30162E+13, 8.30162E+13, 8.30163E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.30168E+13, 8.30169E+13, 8.30169E+13, 8.30169E+13, 8.30168E+13, 8.30169E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.30E+12, 8.30E+13, 8.30E+13, 8.30E+13, 8.30E+13, 8.30166E+13, 8.30E+13, 8.3016E+13, 8.30168E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.3016E+13, IE1100VA02, 835160025, 835160024, 835160017, 835160018, 835160021, 835160022, GOLD001958, GOLD001985, 600010VA01, HU1094VA01, HU1116VA01, HU1205VA01, HU1231VA10, 828160008, 828160007, 2704830INNOVA, H2077VAS27, H17654VAS8, 553003XR01, 10086VAS06, 00060VAS02, 00159VAS04 (10086VAS06), 00192VAS04, 00192VAS05, 00234VAS01, 00282VAS02, 00371VAS01, 00440VAS02, 00440VAS03, 00463VAS06, 00888VAS02, 01065VAS01, 05208VAS02, 05217VAS02, 05451VAS01, 10507VAS01, 00197VAS01, 10086VAS04, A4166952, B1650215, B5483438, M1334109, M2068110, M2569315, M2844529, M4176519, M4183841, M4200108, M4211066, M4496941, B4192944, M2621511, M4198195, M181374801, FI1017VA02, FI1017VA03, FI1025VA01, FEB52055, ME612436, CEE15663, UPW21603, EG1729VA01, EG1029VA01, EG1729VA01, EG1029VA01, EG1741VA01, DZ1006VA01, DK1066VA02, HC4348XR02, PC0052XR07, PC0052XR08, 507902XR01, HC0222XR35, HC4355XR06, HC4480XR05, HC1995XR03, CS1118VA03 (CS1313VA01), CS1006VA04, 2664023INNOVA, 2696283INNOVA, 26814ANGI2, 82416310009, 468668XR01, 905848INNOVA1, 416864INNOVA2, 604875AINNOVA1, 416480INNOVA, 604682INNOVA1, 604682INNOVA2, 604875AINNOVA2, 416864INNOVA, 82416100014, 82416150002, 82416130026, 82416010005, 82416010007, 82416030005, 82416040011, 82416040012, 82416040014, 82416050003, 82416060001, 82416070006, 82416100009, 82416100012, 82416100017, 82416120008, 82416130016, 82416130019, 82416130023, 82416130024, 82416160007, 82416180003, 82416200004, 82416210007, 82416220010, 82416120009, 82416030004, 82416100007, 82416140006, 082416ATCINNOVA, 82416110005, 82416230002, 82416100015, 82416200007, 82416270003, 82416210010, 82416310010, 82416210010, 82416100020, 82416010008, 2673668, 1239682, 2721872, 2632834, 2730446, 010120RX44, 910162009, 910162010, 910162011, 910162012, 910163011, 910163014, 910162013, 910162014, 910162014 and DZ1050VA01, and Serial Numbers: 00000007C20392, 00000007C20251, 00000007C20255, 00000519158BU0, 00000520049BU8, 00000007C20176, 00000007C20336, 00000007C20053, 00000007C20007, 00000499802BU7, 00000489558BU7, 00000519149BU9, 00000489565BU2, 00000519171BU3, 00000464566BU9, 00000459673BU0, 00000519173BU9, 00000464584BU2, 00000489541BU3, 00000007C20047, 00000464568BU5, 00000536791BU7, 00000455797BU9, 00000466853BU9, 00000536785BU9, 00000489696BU5, 00000007C20119, 00000478341BU1, 00000498715BU2, 00000007C20036, 00000459675BU5, 00000046457BU0, 00000536784BU2, 00000519182BU0, 00000466843BU0, 00000520086BU0, 00000520054BU8, 00000464590BU9, 00000520078BU7, 00000007C20019, 00000007C20062, 00000544810BU5, 00000454582BU8, 00000459650BU8, 00000519186BU1, 00000466848BU9, 00000459652BU4, 00000465840BU7, 00000465832BU4, 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00000007C20195, 00000007C20093, 00000538572BU9, 00000519138BU2, 00000007C20193, 00000007C20142, 00000548503BU2, 00000008C20045, 00000007C20349, 00000008C20013, 000000MI003727, 00000008C20017, 00000008C20033, 00000008C20045, 00000008C20059, 00000008C20062, 000000MI003727, 00000008C20004, 00000478328BU8, 00000007C20143, 00000498709BU5, 00000007C20158, 00000007C20286, 00000007C20286, 00000008C20009, 00000007C20140, 00000007C20186, 00000520048BU0, 00000519108BU5, 00000520070BU4, 00000489736BU9, 00000519104BU4, 00000489743BU5, 00000007C20070, 00000007C20171, 00000459661BU5, 00000008C20009, 00000008C20065, 00000465838BU1, 00000466856BU2, 00000007C20315, 00000007C20323, 00000007C20213, 00000007C20267, 00000532658BU2, 00000007C20071, 00000489552BU0, 00000520087BU8, 00000519170BU5, 00000489540BU5, 00000465842BU3, 00000007C20040, 00000464576BU8, 00000464574BU3, 00000465827BU4, 00000007C20269, 00000466847BU1, 00000465835BU7, 00000007C20205, 00000007C20200, 00000007C20350, 00000008C20061, 00000459667BU2, 00000466844BU8, 00000520051BU4, 00000519091BU3, 00000464078BU5, 00000007C20157, 00000007C20380, 00000489681BU7, 00000478319BU7, 00000519121BU8, 00000478347BU8, 00000519181BU2, 00000007C20259, 00000007C20041, 00000498719BU4, 00000489546BU2, 00000478323BU9, 00000465847BU2, 00000007C20306, 00000459678BU9, 00000464573BU5, 00000465834BU0, 00000465836BU5, 00000465823BU3, 00000466854BU7, 00000478326BU2, 00000489536BU3, 00000478336BU1, 00000478348BU6, 00000489555BU3, 00000489549BU6, 00000489747BU6, 00000489729BU4, 00000489722BU9, 00000489737BU7, 00000519099BU6, 00000519176BU2, 00000007C20048, 00000536778BU4, 00000498713BU7, 00000007C20077, 00000007C20044, 00000489733BU6, 00000519136BU6, 00000007C20208, 00000459669BU8, 00000459657BU3, 00000489723BU7, 00000007C20314, 00000007C20265, 00000007C20393, 00000007C20281, 00000007C20281, 00000007C20389, 00000007C20393, 00000008C20072, 00000007C20364, 00000489704BU7, 00000489744BU3, 00000530410BU0, 00000478331BU2, 00000519146BU5, 00000489738BU5, 00000489705BU4, 00000489728BU6, 00000465849BU8, 00000536807BU1, 00000519125BU9, 00000007C20006, 00000465831BU6, 00000489711BU2, 00000532668BU1, 00000489766BU6, 00000519100BU2, 00000520050BU6, 00000498668BU3, 00000498673BU3, 00000489770BU8, 00000007C20106, 00000459662BU3, 00000007C20172, 00000465841BU5, 00000007C20099, 00000007C20364, 00000008C20035, 00000558407BU3, 00000489560BU3, 00000478324BU7, 00000464567BU7, 00000466857BU0, 00000532666BU5, 00000489761BU7, 00000519163BU0, 00000466865BU3, 00000489688BU2, 00000489763BU3, 00000489772BU4, 00000520062BU1, 00000478327BU0, 00000489542BU1, 00000007C20100, 00000007C20133, 00000007C20029, 00000519117BU6, 00000519111BU9, 00000007C20021, 00000007C20079, 00000007C20126, 00000007C20196, 00000007C20223, 00000007C20262, 00000007C20291, 00000007C20282, 00000007C20291, 00000007C20360, 00000007C20386, 00000008C20031, 00000008C20054, 00000489561BU1, 00000555084BU3, 00000007C20309, 00000466855BU4, 00000466864BU6, 00000007C20233, 00000007C20229, 00000007C20085, 00000536786BU7, 00000519097BU0, 00000489726BU0, 00000478322BU1, 00000489694BU0, 00000532663BU2, 00000007C20278, 00000519137BU4, 00000007C20184, 00000489724BU5, 00000459672BU2, 00000007C20268, 00000478343BU7, 00000465833BU2, 00000478343BU7, 00000498689BU9, 00000007C20274, 00000459668BU0, 00000466846BU3, 00000459659BU9, 00000489553BU8, 00000489547BU0, 00000466850BU5, 00000459677BU1, 00000478344BU5, 00000459658BU1, 00000464585BU9, 00000007C20063, 00000519119BU2, 00000007C20107, 00000007C20207, 00000489759BU1, 00000498679BU0, 00000519179BU6, 00000489706BU2, 00000489735BU1, 00000489550BU4, 00000464565BU1, 00000532659BU0, 00000520083BU7, 00000489684BU1, 00000489548BU8, 00000520065BU4, 00000007C20235, 00000007C20178, 00000465798BU7, 00000007C20287, 00000520045BU6, 00000489756BU7, 00000007C20174, 00000519094BU7, 00000007C20069, 00000519106BU9, 00000008C20002, 00000007C20359, 00000007C20366, 00000007C20359, 00000007C20366, 00000008C20060, 00000464588BU3, 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Products Sold
System ID Numbers: ZA2239RX01, 857307IN421, 417347FCV2, 262687CL2, 409938INV21, 516632INNOVA1, 704384CL21, 505848CATH1, 505848EP, 318448INNOVA3, 305682IN2, 410554INNOVA2, 208367INNOVA, 208381CCL1, 2035762100, 717217CA10002 (717217INN21), 843797TCL1, 214947MINNOVA, 214947MINNOVA2, PRESBYDEP, 303839CL2, 252384CATH1, 303788CL1, 4436432100, 4107872100, 8184092100, 864255SFCL2, 219932DCL2, 305364P2100, 954987CL4, 713794LAB1, 727869CATH3, 727869CCL2, 727869EP5, 208227CATH1, 8157412100, 816861KCVAI2, 308865GIN1, 865693CCL, 865693CCL2, 608775NOVA2, 310825INNOVA21, 516562INNOVA6, 516562INNOVA7, 865977CCL, 217383CCL2A, 541732CV2, 251435ICV3, 239436CATH4, 732776CATH4, 212305CATH1, 212604INNOVA1, 65049321, 304424INNOVA, 610983INNOVA2, 201447LAB1, 215453INNOVA21, 253627INNOVA1, 229228INNOV21C, 8053702100, RPINNOVA2100, 303425CL3, 317355INNOVA3, 318448CA1000 (318448INNOVA3), 330363LAB3, 330375LAB2, 336538ARCL1, 360456XCL4, 405604D2100, 408559INV1, 410554INNOVA1, 414291CL2, 414649INNOVA2, 417269SCLA, 417347FCV4, 423495MCATH1, 501257VALAB1, 508856IN21, 509575YM2100, 516562INNOVA2A, 518243LAB1, 518243LAB2, 561548ET2, 570476INNOVA21, 573761SMC2, 573815BCR2, 573815BCR3, 573815BCR4, 574535IN21, 602239CLAB2, 607737CL1, 608775NOVA1, 610250INNOVA1, 610250INNOVA3, 610776INNOVA21, 612273INNOVA2, 615284CV3, 615342CV3, 615446CV1, 617636CL1, 630856H2100, 650369SV4, 651582IN3, 661327INNOVA1, 661327INNOVA2, 706291CLIN1, 713375U2100, 713375UCA, 717217INN21, 717544GECATH2, 717544GECATH3, 718470EP, 718780CATH3, 727942CATH2, 732324INN1, 732923INN, 770HMCCL1, 781340IN1, 781340IN3, 785354HRTEP, 803256PCL5, 808547QCV1A, 808547QCV3A, 812238UN21, 813615CL1, 813615CL8, 813615CL9, 813615EP3, 814452EP, 815759CARDIAC1, 817329BG2100, 843724CL1, 843724CL2, 843724CL3, 843724EP1, 845368LAB1, 845368LAB2, 856853IN2100, 858554INNOVA2, 858554INNOVA3, 864255SFCL1, 904597CATH, 910343EP1, 910343EP2, 910671INOV21, 916781INNOVA2, 937208INNOVA2, 954735CL2, 954987CCL7, 954987CCL8, 970350CL2, 9704CHINNOVA, 973579LAB1, 985898INNOVAA, 985898INNOVAB, CM2100, ECXV1406F, FHOMEP, 508941IN21, 508335INNOVA, 843692CATH3, 828213IN21, 901765EP, 410554INNOVA4, 410554INNOVA3, 251435ICV7, 262255INNOVA2, 303369HCL4, 410337INNOVA6, 573256MHC, 804764CATH2, 845365V13, 7023602100, 9284532100, 336832MCCL6, 402559UCD, 775982INN2100, 847316INNOVA1, 847316INNOVA2, LVINOV7, 0002651218X, 402559UCC, 4105502100XX, 0002507622X, 845368CATH1, 845368CATH2, 262687CL1, 336538ARCL, 619457INNOVA6, 949250I21, 630856H21EP, 202782LABC, 619457INNOVA5, 336538ARCL, 610988INNOVA5, 508422IN21, 630856H21EP, 303629EP2, 853060191, 853060197, 853060193, 853060195, 853060199, 853060199, 34097VAS01, 01031VAS01, 71004VAS01, 06052VAS01, 20001VAS02, 34009VAS06, 34134VAS02, 35049VAS01, 58010VAS01, 80002VAS01, 06004VAS03, 35021VAS02, 34097VAS01, 34280VAS01, SY1001VA02, SY2005VA01, SK1083VA01, SK1064VA01, SK1110VA01 , SI4069VA01, 847160002, 847160003, A004RX01, A020RX13, SD1038VA01, SA1011VA01, SA1054VA02, PER00218, 787844INNOVACL1, 787844INNOVACL2, 787844INNOVACL3, PL1101VA03, 600151VA01, 600042VA03, PL1677VA01, 843160005, 2737019, 2752691, 920169006, NO1009VA03, NO1064VA03, 644INNOVA21, 83INNOVA2588441, 81INOVAISSSTE08, 36INOVA2733687, MA1004VA02, LV4000VA02, LV4000VA03, LV4001VA02, LT4000VA04, LB1042VA01, KW1018VA05, KW1018VA01, KW1018VA02, KW1018VA03, 850060723, 850060729, YV0054, YV0057, YV0058, YV0059, YV0060, YV0061, YV0062, YV0063, YV0064, YV0065, YV0066, YV0067, YV0068, YV0070, YV0071, YV0072, YV0073, YV0074, YV0075, YV0076, YV0077, YV0078, YV0079, YV0080, YV0081, YV0100, YV0055, YV0056, YX1483, YV0082 , YV0083, YV0085, YV0088, YV0088, YV0086, YV0085, YV0090, D5810523, A5129022, A5333036, A5333037, A147111802, A5125125, A5129025, A5131858, A5155141, A5164510, A5219606, A5220710, A5286803, A5400910, A5605743, A5624112, A5800506, A5807919, A58080104, B5120723, C5123625, C5123626, C5323515, A5624127, A5697709, A5764002, B5603933, A5111034, D5810523, IR1748VA01, 8.30E+13, 2644132, 8.3016E+12, 083016002101586 (83016002101581), 8.30161E+13, 8.30162E+13, 8.30162E+13, 8.30162E+13, 8.30163E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.30168E+13, 8.30169E+13, 8.30169E+13, 8.30169E+13, 8.30168E+13, 8.30169E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.30E+12, 8.30E+13, 8.30E+13, 8.30E+13, 8.30E+13, 8.30166E+13, 8.30E+13, 8.3016E+13, 8.30168E+13, 8.30166E+13, 8.30168E+13, 8.30168E+13, 8.3016E+13, IE1100VA02, 835160025, 835160024, 835160017, 835160018, 835160021, 835160022, GOLD001958, GOLD001985, 600010VA01, HU1094VA01, HU1116VA01, HU1205VA01, HU1231VA10, 828160008, 828160007, 2704830INNOVA, H2077VAS27, H17654VAS8, 553003XR01, 10086VAS06, 00060VAS02, 00159VAS04 (10086VAS06), 00192VAS04, 00192VAS05, 00234VAS01, 00282VAS02, 00371VAS01, 00440VAS02, 00440VAS03, 00463VAS06, 00888VAS02, 01065VAS01, 05208VAS02, 05217VAS02, 05451VAS01, 10507VAS01, 00197VAS01, 10086VAS04 , A4166952, B1650215, B5483438, M1334109, M2068110, M2569315, M2844529, M4176519, M4183841, M4200108, M4211066, M4496941, B4192944, M2621511, M4198195, M181374801, FI1017VA02, FI1017VA03, FI1025VA01, FEB52055, ME612436, CEE15663, UPW21603, EG1729VA01, EG1029VA01, EG1729VA01, EG1029VA01, EG1741VA01, DZ1006VA01, DK1066VA02, HC4348XR02, PC0052XR07, PC0052XR08, 507902XR01, HC0222XR35, HC4355XR06, HC4480XR05, HC1995XR03, CS1118VA03 (CS1313VA01), CS1006VA04, 2664023INNOVA, 2696283INNOVA, 26814ANGI2, 82416310009, 468668XR01, 905848INNOVA1, 416864INNOVA2, 604875AINNOVA1, 416480INNOVA, 604682INNOVA1, 604682INNOVA2, 604875AINNOVA2, 416864INNOVA, 82416100014, 82416150002, 82416130026, 82416010005, 82416010007, 82416030005, 82416040011, 82416040012, 82416040014, 82416050003, 82416060001, 82416070006, 82416100009, 82416100012, 82416100017, 82416120008, 82416130016, 82416130019, 82416130023, 82416130024, 82416160007, 82416180003, 82416200004, 82416210007, 82416220010, 82416120009, 82416030004, 82416100007, 82416140006, 082416ATCINNOVA, 82416110005, 82416230002, 82416100015, 82416200007, 82416270003, 82416210010, 82416310010, 82416210010, 82416100020, 82416010008, 2673668, 1239682, 2721872, 2632834, 2730446, 010120RX44, 910162009, 910162010, 910162011, 910162012, 910163011, 910163014, 910162013, 910162014, 910162014 and DZ1050VA01, and Serial Numbers: 00000007C20392, 00000007C20251, 00000007C20255, 00000519158BU0, 00000520049BU8, 00000007C20176, 00000007C20336, 00000007C20053, 00000007C20007, 00000499802BU7, 00000489558BU7, 00000519149BU9, 00000489565BU2, 00000519171BU3, 00000464566BU9, 00000459673BU0, 00000519173BU9, 00000464584BU2, 00000489541BU3, 00000007C20047, 00000464568BU5, 00000536791BU7, 00000455797BU9, 00000466853BU9, 00000536785BU9, 00000489696BU5, 00000007C20119, 00000478341BU1, 00000498715BU2, 00000007C20036, 00000459675BU5, 00000046457BU0, 00000536784BU2, 00000519182BU0, 00000466843BU0, 00000520086BU0, 00000520054BU8, 00000464590BU9, 00000520078BU7, 00000007C20019, 00000007C20062, 00000544810BU5, 00000454582BU8, 00000459650BU8, 00000519186BU1, 00000466848BU9, 00000459652BU4, 00000465840BU7, 00000465832BU4, 00000007C20056, 00000489559BU5, 00000547017BU4, 00000465794BU6, 00000465796BU1, 00000007C20064, 00000007C20101, 00000466851BU3, 00000007C20124, 00000526648BU1, 00000536825BU3, 00000466863BU8, 00000489556BU1, 00000499802BU7, 00000464587BU5, 00000489551BU2, 00000466860BU4, 00000498708BU7, 00000466852BU1, 00000519132BU5, 00000489713BU8, 00000489539BU7, 00000489742BU7, 00000464580BU0, 00000536809BU7, 00000464571BU9, 00000465848BU0, 00000536777BU6, 00000519114BU3, 00000498717BU8, 00000489543BU9, 00000519131BU7, 00000498671BU7, 00000464593BU3, 00000466845BU5, 00000465845BU6, 00000465830BU8, 00000498711BU1, 00000489564BU5, 00000478335BU3, 00000519180BU4, 00000498718BU6, 00000478337BU9, 00000465837BU3, 00000489721BU1, 00000520080BU3, 00000519168BU9, 00000489538BU9, 00000498720BU2, 00000466839BU8, 00000465843BU1, 00000466862BU0, 00000489683BU3, 00000519133BU3, 00000498710BU3, 00000498721BU0, 00000498721BU0, 00000459673BU0, 00000466837BU2, 00000489557BU9, 00000489537BU1, 00000007C20003, 00000464564BU4, 00000478339BU5, 00000478346BU0, 00000498691BU5, 00000519157BU2, 00000489720BU3, 00000464586BU7, 00000520041BU5, 00000465846BU4, 00000498712BU9, 00000466849BU7, 00000465822BU5, 00000466836BU4, 00000465821BU7, 00000478345BU2, 00000498696BU4, 00000007C20035, 00000465826BU6, 00000464572BU7, 00000464578BU4, 00000464577BU6, 00000536799BU0, 00000519101BU0, 00000489731BU0, 00000536776BU8, 00000478333BU8, 00000519189BU5, 00000532667BU3, 00000519175BU4, 00000465828BU2, 00000478338BU7, 00000498664BU2, 00000519115BU0, 00000532671BU5, 00000508755BU6, 00000478342BU9, 00000465829BU0, 00000459679BU7, 00000532661BU6, 00000498723BU6, 00000519140BU8, 00000520044BU9, 00000478330BU4, 00000007C20194, 00000489775BU7, 00000007C20121, 00000498722BU8, 00000007C20191, 00000007C20114, 00000489686BU6, 00000007C20134, 00000007C20091, 00000007C20183, 00000478340BU3, 00000007C20219, 00000459655BU7, 00000465795BU3, 00000459656BU5, 00000459651BU6, 00000007C20201, 00000007C20138, 00000007C20162, 00000007C20195, 00000007C20093, 00000538572BU9, 00000519138BU2, 00000007C20193, 00000007C20142, 00000548503BU2, 00000008C20045, 00000007C20349, 00000008C20013, 000000MI003727, 00000008C20017, 00000008C20033, 00000008C20045, 00000008C20059, 00000008C20062, 000000MI003727, 00000008C20004, 00000478328BU8, 00000007C20143, 00000498709BU5, 00000007C20158, 00000007C20286, 00000007C20286, 00000008C20009, 00000007C20140, 00000007C20186, 00000520048BU0, 00000519108BU5, 00000520070BU4, 00000489736BU9, 00000519104BU4, 00000489743BU5, 00000007C20070, 00000007C20171, 00000459661BU5, 00000008C20009, 00000008C20065, 00000465838BU1, 00000466856BU2, 00000007C20315, 00000007C20323, 00000007C20213, 00000007C20267, 00000532658BU2, 00000007C20071, 00000489552BU0, 00000520087BU8, 00000519170BU5, 00000489540BU5, 00000465842BU3, 00000007C20040, 00000464576BU8, 00000464574BU3, 00000465827BU4, 00000007C20269, 00000466847BU1, 00000465835BU7, 00000007C20205, 00000007C20200, 00000007C20350, 00000008C20061, 00000459667BU2, 00000466844BU8, 00000520051BU4, 00000519091BU3, 00000464078BU5, 00000007C20157, 00000007C20380, 00000489681BU7, 00000478319BU7, 00000519121BU8, 00000478347BU8, 00000519181BU2, 00000007C20259, 00000007C20041, 00000498719BU4, 00000489546BU2, 00000478323BU9, 00000465847BU2, 00000007C20306, 00000459678BU9, 00000464573BU5, 00000465834BU0, 00000465836BU5, 00000465823BU3, 00000466854BU7, 00000478326BU2, 00000489536BU3, 00000478336BU1, 00000478348BU6, 00000489555BU3, 00000489549BU6, 00000489747BU6, 00000489729BU4, 00000489722BU9, 00000489737BU7, 00000519099BU6, 00000519176BU2, 00000007C20048, 00000536778BU4, 00000498713BU7, 00000007C20077, 00000007C20044, 00000489733BU6, 00000519136BU6, 00000007C20208, 00000459669BU8, 00000459657BU3, 00000489723BU7, 00000007C20314, 00000007C20265, 00000007C20393, 00000007C20281, 00000007C20281, 00000007C20389, 00000007C20393, 00000008C20072, 00000007C20364, 00000489704BU7, 00000489744BU3, 00000530410BU0, 00000478331BU2, 00000519146BU5, 00000489738BU5, 00000489705BU4, 00000489728BU6, 00000465849BU8, 00000536807BU1, 00000519125BU9, 00000007C20006, 00000465831BU6, 00000489711BU2, 00000532668BU1, 00000489766BU6, 00000519100BU2, 00000520050BU6, 00000498668BU3, 00000498673BU3, 00000489770BU8, 00000007C20106, 00000459662BU3, 00000007C20172, 00000465841BU5, 00000007C20099, 00000007C20364, 00000008C20035, 00000558407BU3, 00000489560BU3, 00000478324BU7, 00000464567BU7, 00000466857BU0, 00000532666BU5, 00000489761BU7, 00000519163BU0, 00000466865BU3, 00000489688BU2, 00000489763BU3, 00000489772BU4, 00000520062BU1, 00000478327BU0, 00000489542BU1, 00000007C20100, 00000007C20133, 00000007C20029, 00000519117BU6, 00000519111BU9, 00000007C20021, 00000007C20079, 00000007C20126, 00000007C20196, 00000007C20223, 00000007C20262, 00000007C20291, 00000007C20282, 00000007C20291, 00000007C20360, 00000007C20386, 00000008C20031, 00000008C20054, 00000489561BU1, 00000555084BU3, 00000007C20309, 00000466855BU4, 00000466864BU6, 00000007C20233, 00000007C20229, 00000007C20085, 00000536786BU7, 00000519097BU0, 00000489726BU0, 00000478322BU1, 00000489694BU0, 00000532663BU2, 00000007C20278, 00000519137BU4, 00000007C20184, 00000489724BU5, 00000459672BU2, 00000007C20268, 00000478343BU7, 00000465833BU2, 00000478343BU7, 00000498689BU9, 00000007C20274, 00000459668BU0, 00000466846BU3, 00000459659BU9, 00000489553BU8, 00000489547BU0, 00000466850BU5, 00000459677BU1, 00000478344BU5, 00000459658BU1, 00000464585BU9, 00000007C20063, 00000519119BU2, 00000007C20107, 00000007C20207, 00000489759BU1, 00000498679BU0, 00000519179BU6, 00000489706BU2, 00000489735BU1, 00000489550BU4, 00000464565BU1, 00000532659BU0, 00000520083BU7, 00000489684BU1, 00000489548BU8, 00000520065BU4, 00000007C20235, 00000007C20178, 00000465798BU7, 00000007C20287, 00000520045BU6, 00000489756BU7, 00000007C20174, 00000519094BU7, 00000007C20069, 00000519106BU9, 00000008C20002, 00000007C20359, 00000007C20366, 00000007C20359, 00000007C20366, 00000008C20060, 00000464588BU3, 00000459670BU6, 00000519109BU3, 00000498716BU0, 00000489752BU6, 00000489740BU1, 00000519129BU1, 00000459676BU3, 00000007C20084, 00000008C20024, 00000520052BU2, 00000007C20180, 00000520075BU3, 00000007C20136, 00000464579BU2, 00000008C20012, 00000485080BU6, 00000007C20329, 00000007C20305, 00000046582BU1, 00000498683BU2, 00000498680BU8, 00000520071BU2, 00000466841BU4, 00000007C20168, 00000519150BU7, 00000519159BU8, 00000489545BU4, 00000464592BU5, 00000519130BU9, 00000466859BU6, 00000459891BU8, 00000464582BU6, 00000464581BU8, 00000464589BU1, 00000536795BU8, 00000489701BU3, 00000459653BU2, 00000498661BU8, 00000519139BU0, 00000464570BU1, 00000513161BU0, 00000478320BU5, 00000489757BU5, 00000498688BU1, 00000466838BU0, 00000459664BU9, 00000459663BU1, 00000465839BU9, 00000466861BU2, 00000466858BU8, 00000459665BU6, 00000459654BU0, 00000007C20113, 00000548369BU8, 00000007C20228, 00000007C20146, 00000489719BU5, 00000007C20294, 00000007C20277, 00000007C20288, 00000007C20292, 00000007C20288, 00000008C20008, 00000008C20029, 0000007C200899, 00000007C20163, 00000007C20210, 00000007C20156, 00000008C20055, 00000539138BU8, 00000464591BU7, 00000478325BU4, 00000489544BU7, 00000519166BU3, 00000459674BU8, 00000536808BU9, 00000007C20074, 00000007C20355, 00000007C20355, 00000007C20111, 00000007C20243, 00000007C20378, 00000008C20010 and 00000008C20042.
GE Medical Systems, LLC is recalling GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188. 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