GE Medical Systems, LLC GE Innova 4100 / 4100 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 4100 / 4100 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 Number: 304347INNOVA2, 574647IN2, 317621PVAW 317621PV, 248849SP1, 412784LAB1, 412784LAB2, 7087564100, 478765ANG1, 209467INNOVA308, 620665INNOVA41, 409212INOV41, 727398SPEC1, RADNETXV2, MCL4100, 601376SP4100, 718250ANGIO, 615284OR15, 618549CM4100, 419557ORLAB, 3184734100, 706774USP3, 6309784100, 6616324100, 304256INNOVA, 2035764100, 352596SPEC, 423495MSPEC2, 5135844100, 719560INN41, 303320OR41, 303399IR, 303436ANGIO, 3027444100, 574294IN41, 239939INNOVA, 252847PRS3, 864255SF4100, 305823IN4100, 7137764100, 3016094100, 414649CL2, 812858GWSP, 212639ACT1, 8014794100, 304424CCINOVA, 309655FSP1A, 4134474100, 5033704100, 509474SH41, 201541SP1, 281401T4100, 918744JR4100, 22925941V2, 586573SP1, 314569SJRM12, 314966DPHSP, 317887INNOVAPV, 330489SPEC9, 352333INVOR, 386254HS1, 386254HS2, 386HPOS1, 404466SF41A, 404GHSIR1, 410337INNOVA2, 412647OR10, 414649DVI, 419696LAB1, 505848CATH2, 505848V4100, 508650IN41, 509482HFI, 512901NI4100, 530888ANG206, 541686SPR1, 561548VAS2, 570321LAB2, 605333RM10, 610988INNOVA4, 617636IN1, 619229INNOVA1, 623848SP, 630275G41, 630275G41B, 650493ANGIOCT, 662244GTSP, 678EJCIR1, 706291RINN2, 706651SP1, 706733SP1, 708783CL4100, 708783SP4100, 713375U4100, 718630LIBERTY, 727791INNOVA, 770535N4100, 803256SP, 804594ANGIO, 812238UN41, 812825INNOVA1, 813615CL10, 815740SC4100, 817465AR4100, 817922BA4100, 843577CL2, 845368RM10, 850747IN4100, 863687INV24, 864573LAB2, 865373SP, 865481SUR, 908522SP1, 915577SP1, 918682IN41, 954MW4100, 970247INNOVA, COR359867, DR4100, FHORL4100, PEMBROKE4100, RADNETXV1, RHD4100, 480512SP, 8458584100, 770736SP1, 423495M4100E, 423493I4100, 8593134100, 313343SP1, 708202VA41, 708WESTSUB4100, 509575YM4100, 80140841, 80180741, 2194654100, 4082594100, 4105434100, 4137484100, 5094744100, 5417684100, 5703214100, 5705224100, 6082634100, 7023604100, 7028804100, 219326IN41, 229228INNOV41C, 22925941V, 251435I12, 252816INNOVA, 269226IN1, 269226IN2, 269983IN41, 303839CL1, 308534ANG, 309672M4100, 312792R4100, 313876SP41, 316651INNOVA41, 317338PV3, 360754INNOVA, 401274IN41, 412623LAB1, 412623LAB3, 414328INN4100, 419251LAB1, 508383IN4100, 512528CPCL1, 541282CV2, 603650ANG1, 608263ACT, 608263XMR, 608324DAL, 610954INNOVA41, 617525IN1XX (617525IN1), 617726RF2Y6, 626359INNOVA, 650369SV5, 706291RINN, 718206LIBERTY1, 760633IR1, 773878SWGANGIO1, 801268INNOVA, 804285CATH2, 804764CATH3, 810342A41, 813558INTV, 816943SP1, 817433HSW4100, 828298VASC, 847842GS4100, 856365ANGIO, 903GS4100, 904202SP1, 904BSSP, 913317SLS4100, 952993INNOVA2, 972335LIB, 972487ANGIO1, 972566INNOVA3, 985867INNOVA2, ECXV1406E, MIRAMAR41, WCATHLAB41, 334286BSP, 757889INNOVA, 706278INNOVA1, 561747IN4, 252847PRS2, 918744JC4100, 5136864100, 850494WSP1, FWANG3217, 309343CSP1A, 309655FSP3A, 802295VALCA, 574647IN41, 480512SPUPS (480512SP), 843674VAS1, 630275AW41 (630275G41B), 0002651236AX (813745INTV), 414328INNAW (414328INN4100), 317621PV, 630275AW41B (630275G41B), 316962INNOVA41, 906485ANGIO, 4135344100, 85931341002, 423495ENDO2, 847316INNOVA41, 215537INNOVA1, 561784INSP, 4436434100, 843797TIR2, 305835IN41, 303839CL1, 318681INNOVA1, 853060196, 853060187, 06004VAS02, SK1110VA02, E001RX08, SA1005VA06, RU2278VA01, 600152VA01, RU2714VA01, RU2992VA01, RU1050VA03, RU1106VA02, RU1326VA01, 787620IN4100, 787653INNOVA, 600042VA02, NO1037VA01, NO1015VA04, BRD0411, MA1251VA01, MA1020VA01, LT4001VA02, LB1037VA01, KW1001VA03, KW1001VA04, KW1018VA04, KW1013VA01, 850060718, 850060720, 850060721, 850060722, 850060725, 850060707, YV0012, XF0150, XF0151, XF0152, XF0153, XF0154, XF0155, XF0200, YV0006, YV0007, XF0156, YV0009, XF0022, XF0149, YV0001, YV0002, YV0004, YV0010, XF0157, YV0012, B5129910, A5102671, A5163317, A5605732, A5105151, C5603903, 8.30062E+13, IL1043VA01, IE1100VA01, HU1039VA02, 00490VAS02, 01278VAS01, 10091VAS01, 00137VAS01, 00171VAS01, 00860VAS01, 00065VAS01, M2030711, M1230007, N4192927, R4211476, M4505274, FI1015VA01, DE641223, DE188442, HC0220XR07, 407953XR01, 487692XR01, UC1129XR33, 600002VA01, CS1054VA01, 514842AINNOVA, 613548INNOVA3, 4163694100, 250370INNOVA, 306766INNOVA, 416756INNOVA, 514376INNOVA, 514934BANGIO, 519663INNOVA2, 519685INNOVA, 204787INNOVA1, 604557INNOVA, 82406070010, 82406310005, 82416030007, 82416040020, 82416100016, 82416130020, 82416130021, 82416130025, 82416220006, 82406040022, 82406120016, 82416130010, 82416130011, 82416130013, 82416140005, 82416160005, 82416160010 and 190020RX09, and Serial Numbers: 00000008C20030, 00000008C20052, 00000008C20051, 00000556127BU9, 00000007C20218, 00000007C20337, 00000007C20148, 00000007C20308, 00000007C20312, 00000007C20249, 00000007C20320, 00000007C20362, 00000008C20038, 00000007C20330, 00000008C20001, 00000007C20316, 00000008C20020, 00000007C20341, 00000008C20034, 00000464131BU2, 00000524362BU1, 00000513090BU1, 00000477792BU6, 00000520079BU5, 00000464074BU4, 00000471490BU3, 00000007C20020, 00000453906BU0, 00000453926BU8, 00000464072BU8, 00000536790BU9, 00000519096BU2, 00000513264BU2, 00000500002BU1, 00000498705BU3, 00000509203BU6, 00000453942BU5, 00000519155BU6, 00000007C20061, 00000464109BU8, 00000453949BU0, 00000464111BU4, 00000477747BU0, 00000489730BU2, 00000532657BU4, 00000007C20023, 00000477757BU9, 00000489700BU5, 00000464077BU7, 00000477761BU1, 00000520074BU6, 00000435073BU2, 00000468194BU6, 00000007C20104, 00000512862BU4, 00000532665BU7, 00000520056BU3, 00000513243BU6, 00000477764BU5, 00000520068BU8, 00000498686BU5, 00000486695BU7, 00000519169BU7, 00000498881BU2, 00000532664BU0, 00000519127BU5, 00000489691BU6, 00000444314BU9, 00000536779BU2, 00000489687BU4, 000782415-0004, 00000477838BU7, 00000511702BU3, 000000M1001348, 00000477819BU7, 00000536787BU5, 00000498699BU8, 00000444274BU5, 00000477763BU7, 00000477820BU5, 00000444324BU8, 00000489698BU1, 00000497530BU6, 00000489751BU8, 00000520063BU9, 00000520067BU0, 00000498883BU8, 00000509209BU3, 00000539172BU1, 00000536801BU4, 00000498670BU9, 00000477831BU2, 00000477835BU3, 00000512694BU1, 00000464076BU9, 00000464045BU4, 00000498880BU4, 00000444312BU3, 00000519095BU4, 000000M1002692, 00000498255BU9, 00000516593BU1, 00000489760BU9, 00000520081BU1, 00000489746BU8, 00000464084BU3, 00000007C20002, 00000477801BU5, 00000498669BU1, 00000519123BU4, 00000498677BU4, 00000453925BU0, 00000489692BU4, 00000489697BU3, 00004822458BU7, 9, 00000498665BU9, 00000489777BU3, 00000539078BU6, 00000519120BU0, 00000477790BU0, 00000464048BU8, 00000007C20103, 00000007C20095, 00000007C20094, 00000464091BU8, 00000479633BU0, 00000520072BU0, 00000007C20081, 00000007C20016, 00000464053BU8, 00000007C20128, 00000530219BU5, 00000498090BU0, 00000513169BU3, 00000067074VE5, 00000441179BU9, 00000099706VE4, 00000526668BU9, 00000526647BU3, 00000444278BU6, 00000444289BU3, 00000093713VE6, 00000007C20130, 00000479569BU6, 00000067042VE2, 00000466840BU6, 00000444365BU3, 00000528662BU0, 00000479541BU5, 00000444306BU5, 00000067069VE5, 00000444319BU8, 00000498150BU2, 00000437229BU8, 00000513215BU4, 00000498247BU6, 00000437332BU0, 00000477785BU0, 00000451589BU6, 00000444279BU4, 00000067077VE8, 00000526544BU2, 00000526673BU9, 00000067056VE2, 00000513101BU6, 00000444298BU4, 00000007C20028, 00000479498BU8, 00000498074BU4, 00000441209BU4, 00000526354BU6, 00000513520BU7, 00000403984BU8, 00000526300BU9, 00000512684BU2, 00000435074BU0, 00000479553BU0, 00000498091BU8, 00000008C20155, 00000444268BU7, 00000093715VE1, 00000444264BU6, 00000479552BU2, 00000526535BU0, 00000067053VE9, 00004411628BU2, 00000512835BU0, 00000526652BU3, 00000444252BU1, 00000479551BU4, 00000093721VE9, 00000526651BU5, 00000526552BU5, 00000526676BU2, 00000007C20204, 00000444277BU8, 00000526530BU1, 00000411063BU1, 00000530105BU6, 00000512746BU9, 0000000000LIB7, 00000498257BU5, 00000432299BU6, 00000444239BU8, 00000055093VE9, 00000434364BU6, 00000067064VE6, 00000077916VE5, 000786324-0006, 00000416900BU9, 00000077914VE0, 00000403215BU7, 00000007C20345, 00000007C20239, 00000007C20127, 00000441207BU8, 00000007C20103, 00000007C20139, 00000477811BU4, 00004986775BU8, 00000513125BU5, 00000008C20051, 00000477811BU4, 00000008C20049, 00000007C20301, 00000007C20370, 00000008C20016, 00000008C20019, 00000008C20043, 00000008C20053, 00000008C20063, 00000008C20066, 00000008C20067, 00000008C20069, 00000498150BU2, 00000008C20064, 00000007C20160, 00000093730VE0, 00000513250BU1, 00000008C20028, 00000479536BU5, 00000489745BU0, 00000007C20357, 00000477771BU0, 00000519098BU8, 00000453917BU7, 00000520060BU5, 00000512708BU9, 00000007C20280, 00000510196BU9, 00000441173BU2, 00000464083BU5, 00000008C20050, 00000526536BU8, 00000444262BU0, 00000007C20367, 00000479532BU4, 00000536806BU3, 00000498660BU0, 00000512721BU2, 00000007C20046, 00000489727BU8, 00000067072VE9, 00000453940BU9, 00000479528BU2, 00000477754BU6, 00000489682BU5, 00000477806BU4, 00000479485BU5, 00000008C20023, 00000485917BU9, 00000477742BU1, 00000513522BU3, 00000513142BU0, 00000489693BU2, 00000498694BU9, 00000489734BU4, 00000486219BU9, 00000477773BU6, 00000007C20153, 00000007C20188, 00000539161BU0, 00000441206BU0, 00000416899BU3, 00000479482BU2, 00000526531BU9, 00000007C20283, 00000007C20333, 00000008C20023, 00000007C20339, 00000489780BU7, 00000477822BU1, 00000513229BU5, 00000479533BU2, 000000MI000553, 00000489768BU2, 00000489699BU9, 00000007C20271, 00000441210BU2, 00000453951BU6, 00000477781BU9, 00000477832BU0, 00000479503BU5, 00000427306BU6, 00000007C20169, 00000007C20369, 00000007C20388, 00000007C20052, 00000512723BU8, 00000007C20150, 00000444316BU4, 00000007C20245, 00000007C20353, 00000007C20342, 00000412256BU0, 00000519103BU6, 00000512909BU3, 00000007C20149, 00000441208BU6, 00000477776BU9, 00000477841BU1, 00000479480BU6, 00000512728BU7, 00000453939BU1, 00000077892VE8, 00000526543BU4, 00000406451BU5, 00000526289BU4, 00000512669BU3, 00000536796BU6, 00000007C20363, 00000444273BU7, 00000464075BU1, 00000007C20032, 00000519161BU4, 00000519165BU5, 00000477824BU7, 00000477837BU9, 00000498701BU2, 00000435347BU0, 00000055098VE8, 00000479478BU0, 00000067049VE7, 00000077906VE6, 00000440231BU9, 00000536813BU9, 00000444241BU4, 00000519151BU5, 00000530103BU1, 00000007C20001, 00000007C20348, 00000007C20356, 00000007C20394, 00000008C20021, 000000MI003729, 000000MI003730, 000000MI002723, 000000MI003726, 00000491249BU9, 00000491262BU2, 00000491264BU8, 00000498145BU2, 00000499885BU2, 00000499886BU0 and 00000499893BU6.
Products Sold
System ID Number: 304347INNOVA2, 574647IN2, 317621PVAW 317621PV , 248849SP1, 412784LAB1, 412784LAB2, 7087564100, 478765ANG1, 209467INNOVA308, 620665INNOVA41, 409212INOV41, 727398SPEC1, RADNETXV2, MCL4100, 601376SP4100, 718250ANGIO, 615284OR15, 618549CM4100, 419557ORLAB, 3184734100, 706774USP3, 6309784100, 6616324100, 304256INNOVA, 2035764100, 352596SPEC, 423495MSPEC2, 5135844100, 719560INN41, 303320OR41, 303399IR, 303436ANGIO, 3027444100, 574294IN41, 239939INNOVA, 252847PRS3, 864255SF4100, 305823IN4100, 7137764100, 3016094100, 414649CL2, 812858GWSP, 212639ACT1, 8014794100, 304424CCINOVA, 309655FSP1A, 4134474100, 5033704100, 509474SH41, 201541SP1, 281401T4100, 918744JR4100, 22925941V2, 586573SP1, 314569SJRM12, 314966DPHSP, 317887INNOVAPV, 330489SPEC9, 352333INVOR, 386254HS1, 386254HS2, 386HPOS1, 404466SF41A, 404GHSIR1, 410337INNOVA2, 412647OR10, 414649DVI, 419696LAB1, 505848CATH2, 505848V4100, 508650IN41, 509482HFI, 512901NI4100, 530888ANG206, 541686SPR1, 561548VAS2, 570321LAB2, 605333RM10, 610988INNOVA4, 617636IN1, 619229INNOVA1, 623848SP, 630275G41, 630275G41B, 650493ANGIOCT, 662244GTSP, 678EJCIR1, 706291RINN2, 706651SP1, 706733SP1, 708783CL4100, 708783SP4100, 713375U4100, 718630LIBERTY, 727791INNOVA, 770535N4100, 803256SP, 804594ANGIO, 812238UN41, 812825INNOVA1, 813615CL10, 815740SC4100, 817465AR4100, 817922BA4100, 843577CL2, 845368RM10, 850747IN4100, 863687INV24, 864573LAB2, 865373SP, 865481SUR, 908522SP1, 915577SP1, 918682IN41, 954MW4100, 970247INNOVA, COR359867, DR4100, FHORL4100, PEMBROKE4100, RADNETXV1, RHD4100, 480512SP, 8458584100, 770736SP1, 423495M4100E, 423493I4100, 8593134100, 313343SP1, 708202VA41, 708WESTSUB4100, 509575YM4100, 80140841, 80180741, 2194654100, 4082594100, 4105434100, 4137484100, 5094744100, 5417684100, 5703214100, 5705224100, 6082634100, 7023604100, 7028804100, 219326IN41, 229228INNOV41C, 22925941V, 251435I12, 252816INNOVA, 269226IN1, 269226IN2, 269983IN41, 303839CL1, 308534ANG, 309672M4100, 312792R4100, 313876SP41, 316651INNOVA41, 317338PV3, 360754INNOVA, 401274IN41, 412623LAB1, 412623LAB3, 414328INN4100, 419251LAB1, 508383IN4100, 512528CPCL1, 541282CV2, 603650ANG1, 608263ACT, 608263XMR, 608324DAL, 610954INNOVA41, 617525IN1XX (617525IN1), 617726RF2Y6, 626359INNOVA, 650369SV5, 706291RINN, 718206LIBERTY1, 760633IR1, 773878SWGANGIO1, 801268INNOVA, 804285CATH2, 804764CATH3, 810342A41, 813558INTV, 816943SP1, 817433HSW4100, 828298VASC, 847842GS4100, 856365ANGIO, 903GS4100, 904202SP1, 904BSSP, 913317SLS4100, 952993INNOVA2, 972335LIB, 972487ANGIO1, 972566INNOVA3, 985867INNOVA2, ECXV1406E, MIRAMAR41, WCATHLAB41, 334286BSP, 757889INNOVA, 706278INNOVA1, 561747IN4, 252847PRS2, 918744JC4100, 5136864100, 850494WSP1, FWANG3217, 309343CSP1A, 309655FSP3A , 802295VALCA , 574647IN41, 480512SPUPS (480512SP), 843674VAS1, 630275AW41 (630275G41B), 0002651236AX (813745INTV), 414328INNAW (414328INN4100), 317621PV, 630275AW41B (630275G41B), 316962INNOVA41, 906485ANGIO, 4135344100, 85931341002, 423495ENDO2, 847316INNOVA41, 215537INNOVA1, 561784INSP, 4436434100, 843797TIR2, 305835IN41, 303839CL1, 318681INNOVA1, 853060196, 853060187, 06004VAS02, SK1110VA02, E001RX08, SA1005VA06, RU2278VA01, 600152VA01, RU2714VA01, RU2992VA01, RU1050VA03, RU1106VA02, RU1326VA01, 787620IN4100, 787653INNOVA, 600042VA02, NO1037VA01, NO1015VA04, BRD0411, MA1251VA01, MA1020VA01, LT4001VA02, LB1037VA01, KW1001VA03, KW1001VA04, KW1018VA04, KW1013VA01, 850060718, 850060720, 850060721, 850060722, 850060725, 850060707, YV0012, XF0150, XF0151, XF0152, XF0153, XF0154, XF0155, XF0200, YV0006, YV0007, XF0156, YV0009, XF0022, XF0149, YV0001, YV0002, YV0004, YV0010, XF0157, YV0012, B5129910, A5102671, A5163317, A5605732, A5105151, C5603903, 8.30062E+13, IL1043VA01, IE1100VA01, HU1039VA02, 00490VAS02, 01278VAS01, 10091VAS01, 00137VAS01, 00171VAS01, 00860VAS01, 00065VAS01, M2030711, M1230007, N4192927, R4211476, M4505274 , FI1015VA01, DE641223, DE188442, HC0220XR07, 407953XR01, 487692XR01, UC1129XR33, 600002VA01, CS1054VA01, 514842AINNOVA, 613548INNOVA3, 4163694100, 250370INNOVA, 306766INNOVA, 416756INNOVA, 514376INNOVA, 514934BANGIO, 519663INNOVA2, 519685INNOVA, 204787INNOVA1, 604557INNOVA, 82406070010, 82406310005, 82416030007, 82416040020, 82416100016, 82416130020, 82416130021, 82416130025, 82416220006, 82406040022, 82406120016, 82416130010, 82416130011, 82416130013, 82416140005, 82416160005, 82416160010 and 190020RX09; and Serial Numbers: 00000008C20030, 00000008C20052, 00000008C20051, 00000556127BU9, 00000007C20218, 00000007C20337, 00000007C20148, 00000007C20308, 00000007C20312, 00000007C20249, 00000007C20320, 00000007C20362, 00000008C20038, 00000007C20330, 00000008C20001, 00000007C20316, 00000008C20020, 00000007C20341, 00000008C20034, 00000464131BU2, 00000524362BU1, 00000513090BU1, 00000477792BU6, 00000520079BU5, 00000464074BU4, 00000471490BU3, 00000007C20020, 00000453906BU0, 00000453926BU8, 00000464072BU8, 00000536790BU9, 00000519096BU2, 00000513264BU2, 00000500002BU1, 00000498705BU3, 00000509203BU6, 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GE Medical Systems, LLC is recalling GE Innova 4100 / 4100 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