—#73724

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.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050489, K052157, K052412, K061163
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-06-17
Posted by FDA: 2009-06-19
Terminated: 2014-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73724. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.