Devices

Device Recall Innova

  • Model / Serial
    404712SP8 301295EP 309655FSP4A 410740CV 4144473131 540776LGVAS2 541382BP 561881BP1 617525IN13131 630856H3131 630933INVLAB4 718579INNOVABP 773RES3131BP 814877BP 8184093131 COR373252 COR373295 COR373301 ECXV1402B 0853060202 RO1095VA01 0834160005 LY1086VA01 YV0462 A5632421 0853060200 0835160028 00440VAS04 N4192939 2014183100 201541LAB2 201996LAB1 202782LABB 2036883100 205783BCL5 205877CCL2 207351YCL1 207879CL131 208227CATH2 209334LINNOVA1 214324INNOVA2 215335INNOVA1 215576INNOVA1 2197573100 219877IN31 228818VASC 239513CRLAB1 239939CLA 251435ICV6 253968INNOVA 254742KDCL1 262687CL3 281420LAB1 281420LAB23100 281440CL3 2815993100 303425CL4 303629EP 305364P3100 309691P3100 310319SM3100 310423INNOVA1 312STMNAZ3100 313593IC1 314525STACL2 314768SMCL1A 314768SMCL3 316268INNOVAA 316651INNOVA31 316689INNOVA31 316962WCVC1 316962WCVC2 318254CL 334418CL 352333CATH2 352401CATH2 360456XCL3 360SJ3100 361857CATH1 404686CRI3 405272SCL2 405307HCL2 405372S3100 405610NW3100 405636ISW3100 405840OIC3100 409899LAB3 4103323100 4103623100 412232D 412437INNOVA 412623LAB2 413447CATH 413540IN1 414447CL1 414647CL1 414649CL3 414805INNOVA1 417269SCLD 417347FCV5 417885JCL7 417885JCL8 423844CCL1 478274CTH1 479441CV1 479441SP3100 480728LAB2 480821IN2 502587LAB1 502587LAB4 5033703100 5034353100 504447INNOVA2 508856IN2 508941IN1 509946CATH2 512901NI3100 516562INNOVA9 516663INNOVA1A 516663INNOVA2 530244XC106 540953INNOVA 541382CV3 541472CV1 541MWHINNOVA 561266IN31 563421CATHLAB8 570476INNOVA31 573632CRC2 573815BCR1 573882UMC1 575521CATHB 6012883100CV2 601553CL3 602239LAB4 602239LAB6 602266LAB2 606216CATH1 608524NOVA 609267IN3100 609597IN3100 609757IN3100 610447CL1 610526LAB1 610526LAB2 610891CL1 615338CV2 617732IN9 617754IN31 617789IN1 619340VA8 619482INNOVA1 619541INNOVA31 619552INNOVA1 620225INNOVA31 630856H31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 650723SC2 650938LY31 662377CV4 678957INNOVA 7022333100 702616INNOVA 7028803100A 704355PCL 704878CL31 706481CCL 706774HT8 7133933100 713776M3100 713794LAB7 713794LAB9 714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31B 718250CATH1 718270INNOVA1 718283INNOVA3 720225CL2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV 732776CATH2 732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1 770HMCCL2 773792CL3100 773NORWG3100 775982CATH2 8019643100 803256PCL1 803329CL31 803776CL1 804285CATH1 8053703100 808485INNOVA 812237THR31 812238LIB1 812283IN31 812450CATH1 812450EP1 812482INNOVA 812858GWLAB1 812858GWLAB2 814231C1 814676C1 815226INN2 815226OSFLAB1 815344CARDIAC3 815599FHN3100 815756KCHSPEC 816478MC1 816861KCVAI1 816969LSCATH 816985NKCI 817433HSW3100 8184093100 8189813100XX 843692CATH2 843797TCL2 845365V19 847362CONCATH4 850469BCV1 850678IN3100 850747BR3100 856596IN3100 8613100 864512CL3 865481CCL2 865693CCL1 901516R3 903HC3100 903UT3100 904202CATH3 908522LAB1 909464IN3 909788INNOVA1 909CH3100 910343NHIN4 912486CATH1 918333JPIN1 918494IN31A 919731WMINOV 919784REP1 9202623100 925779INNOVA408 928779INNOVA1 931459CV1 936266CL1 940626DCH3100 941798CLAB2 952993INNOVA5 956389INN31 956698INN31 956994INN1 956994INN2 970350CL1 9734293100 973877LAB4 973971LAB3 979MGINV31 985966INNOVA BPINNOVA1 BPINNOVA2 BPINNOVA3R BPINNOVA5 ECXV1406B FHORLCL1 FHORLCL7 KMC3100 LVINOV4 MCDCATH4 YV0036 UA4230VA01 21007VAS02 44009VAS01 34078VAS01 SA1010VA02 RU1295VA02 RU1354VA01 RU3260VA01 600098VA01 600123VA02 600130VA01 RU1001VA02 RU1013VA02 RU1102VA02 RU1142VA01 RU1156VA01 RU1254VA01 RU1295VA04 RU1475VA01 RU1550VA01 RU1899VA01 RU1913VA02 RU2442VA01 RU2457VA01 RU2558VA01 RU2581VA01 RU2741VA01 RU2747VA01 RU2886VA01 RU2969VA01 RU3092VA01 RU3305VA01 787844INNOVACL4 PL1008VA02 PL1082VA01 PL1491VA01 PL1553VA01 PL1650VA02 PL1681VA01 2048000INNOVA 2664627INNOVA 2685467INNOVA 2716439INNOVA NO1005VA05 0834160003 1257060INNOVA 477XVIN2553211 52XVINN2565367 818INNOVAHM1 818INNOVAHM2 818INNOVAHMS1 83INNOVA1188379 INNOVA2762218 LB1003VA01 LB1160XR07 0850060719 0850060724 0850060726 0850060727 YV0172 YV0022 YV0023 YV0024 YV0025 YV0026 YV0027 YV0028 YV0029 YV0030 YV0034 YV0035 YV0037 YV0043 YV0048 YV0050 YV0166 YV0167 YV0170 YV0171 YV0175 YV0176 JO1000VA01 A5105732 A5108239 A5125119 A5162256 A5203215 A5718004 B5274834 B5332001 IR1747VA01 IR1819VA01 IQ1083VA01 IQ1165VA01 082416040026 082416060004 IL1098VA01 0835160023 HU1099VA04 24516572980IN H1420VAS04 H4672VAS02 GE1004VA01 00203VAS01 01243VAS03 01367VAS02 M2002624 M2148236 M2848425 M2970614 M4016034 M40480151 M4163030 M4198062 M9162723 FI1064VA01 FI1314VA02 DPL32931 FPA99414 FPG30528 FPG93008 MPX82206 2655786INNOVA 2625365INNOVA 2735407INNOVA 082416160018 082416250004 082416010006 082416020005 082416030003 082416030006 082416030008 082416030010 082416040010 082416040015 082416040016 082416040018 082416040022 082416040028 082416060002 082416070004 082416080001 082416100006 082416100008 082416100010 082416100013 082416110002 082416110003 082416110004 082416120005 082416120006 082416120007 082416120010 082416120011 082416120012 082416120017 082416130015 082416130017 082416140002 082416140003 082416150001 082416160003 082416160006 082416160011 082416160012 082416160013 082416160014 082416160017 082416180004 082416190001 082416190002 082416190003 082416210003 082416210004 082416210006 082416210009 082416210012 082416210015 082416220008 082416220009 082416230005 082416270002 082416290002 082416310003 082416310006 BY4067VA02 BY4069VA01 BY4066VA01 BY4072VA01 2573329 2667313 2676587 2703876 2722497 2722671 2728403 140024RX09 0910064009 0910064007 0910064008 0910162006 0910163006 0910163007 0910163009 0910163012 0910163015 2722INV31 4127INV31 AE1005VA01 3882569347VAMET 388262854VASCTR 3882643330VACTR 3882643435RXAND 388567772VASMET TT-2577762-CO TT-2586581-CO
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.
  • Product Description
    Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

92 devices with a similar name

Learn more about the data here

Device Recall Innovasis Excella II Standard
  • Model / Serial
    E2S47525 Lot 1301 and E2S47535 Lot 1301
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
  • Product Description
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
  • Manufacturer
    Innovasis, Inc
Device Recall Innova 2100IQ
  • Model / Serial
    505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 208381CCL1 2035762100 717217CA10002 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 0002507622 310825INNOVA21 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 0002698287 0002698301 251435ICV3 239436CATH4 732776CATH4 212305CATH1 212604INNOVA1 65049321 304424INNOVA 610983INNOVA2 201447LAB1 215453INNOVA21 253627INNOVA1 229228INNOV21C 8053702100 RPINNOVA2100 303425CL3 305682IN2X 317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 336538ARCL1 360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA 417347FCV4 423495MCATH1 501257VALAB1 508335CA1 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 815741CA1000 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  0910162009 0910162010 0910162011 0910162012 0910163011 0910163014 0910162013 010120RX44 0002673668 2673668/0002673668 082416100014 082416150002 082416100011 082416130026 082416010005 082416010007 082416030005 082416040011 082416040012 082416040014 082416050003 082416060001 082416070006 082416100009 082416100012 082416100017 082416120008 082416130016 082416130019 082416130023 082416130024 082416160007 082416180003 082416200004 082416210007 082416220010 082416120009 82416030004 82416100007 82416140006 082416ATCINNOVA 82416110005 82449150034 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 416864INNOVA 468668XR01 26814ANGI2 2664023INNOVA CS1118VA03 CS1006VA04 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 HC4480XR05 DK1066VA02 DZ1006VA01 FEB52055 ME612436 CEE15663 FI1017VA02 FI1017VA03 FI1025VA01 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 B4192944 M2621511 M4198195 M181374801 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 05451VAS01 10507VAS01 00197VAS01 10086VAS04  H2077VAS27 H17654VAS8 H0002VAS66 0828160007 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 HU1231VA10 HU1099VA02 0835160017 0835160018 835160021 IE1100VA02 0002644132 08301600206936 083016002101586 083016102100795 083016202101036 083016202101917 083016242100936 083016282101457 083016602101386 083016802100516 083016802100866 083016802100916 083016862101407 083016862101656 083016862101916 83016802100337 83016862100377 083016602101807 083016802101197 083016822101187 8.30168E+12 8.30162E+13 8.30162E+13 2673438 8.30161E+13 A5333036 A5333037 A147111802 A5125125 A5129025 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 B5219603 C5123625 C5123626 C5323515 A5624127 A5697709 A5764002 B5603933 YV0053 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0075 YV0076 YV0077 YV0078 YV0079 YV0080 YV0081 YV0100 YV0055 YV0056 YX1483 YV0082  0850060723 KW1018VA05 KW1018VA01 KW1018VA02 KW1018VA03 LT4000VA04 LV4000VA02 LV4000VA03 LV4001VA02 MA1004VA02 0002679402 0002684003X 644INNOVA21 83INNOVA2588441 NO1009VA03 NO1064VA03 920169006 600151VA01 600042VA03 0002674834 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 PER00218 SA1011VA01 SA1054VA02 SD1038VA01 A004RX01 A020RX13 0847160002 0847160003 2682877 SK1110VA01  SY1001VA02 SY2005VA01 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 06004VAS03 35021VAS02 0853060191 853060197, and  853060193
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including 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; the United States territory of Puerto Rico; and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ,FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND,NORWAY, PANAMA, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI AR ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, and VENEZUELA.
  • Product Description
    GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) 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.
  • Manufacturer
    GE Medical Systems, LLC
Device Recall Innova 3100/3100IQ
  • Model / Serial
    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 0002595303 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 410740CV 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 8185023100 0002686429X 312STMNAZ3100 630312B31  717782INNOVA31B 727725CATH2  785354S3100  918333JPIN2  378INV31 0910064009 0910163012 0910163013 0910163015 910064007 910064008 910162006 910162008 910163006 910163007 910163009 BA4080VA01 140024RX09 BG4549VA02 2573329 2667313 2676587 BE5003VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416170002 82416030003 82416030008 82416030010 82416100006 82416100010 82416100019 82416120007 82416120011 82416130015 82416160003 82416160006 82416210003 82416210004 82416310007 082416220009 82416130017 82416030009 82416120012 82416180005 82416310008 2625365INNOVA 2645993INNOVA CS1006VA03 HC4348XR01 0002655786 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 FPA99414 FI1064VA01 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 M2848425 M2970614 M4016034 M40480151 A9190149 M40480167 00203VAS01 01367VAS02 GE1005VA01 HU1099VA04 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 A5125119 JO1000VA01 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 0850060719 0850060724 0850060726 0850060727 0850060728 KW1055VA01 52XVINN2565367 818INNOVAHM2  477XVIN2553211 0834160003 NO1005VA05 0920169007 2048000INNOVA 2664627INNOVA 2685467INNOVA PL1082VA01 600098VA01 RU1482VA02 RU1475VA01 RU1142VA01 RU2581VA01 SA1010VA02 01012VAS01 41018VAS01 58002VAS01 60001VAS01 34268VAS01 0853060194, and  388567772VASMET
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including 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; the United States territory of Puerto Rico; and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ,FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND,NORWAY, PANAMA, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI AR ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, and VENEZUELA.
  • Product Description
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) 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.
  • Manufacturer
    GE Medical Systems, LLC
Device Recall Innova 4100/4100IQ
  • Model / Serial
    "0002651236A  813745INTV" 0002701957A 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 SHOWCASE4100 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 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 0002520549AX 252816INNOVA 309343CSP1A  309655FSP3A  802295VALCA  190020RX09 082406070010 082406310005 082416030007 082416040020 082416100016 082416130020 082416130021 082416130025 082416220006 82406040022 82406120016 82416130010 82416130011 82416130013 82416140005 82416160005 82416160010 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA 416756INNOVA 514376INNOVA 514934BANGIO 519663INNOVA2 519685INNOVA 204787INNOVA1  CS1054VA01 HC0220XR07 407953XR01 487692XR01 UC1129XR33 FI1015VA02 FI1015VA01 M1230007 N4192927 R4211476 M4505274  00490VAS02 01278VAS01 10091VAS01 00095VAS07 00137VAS01 00171VAS01 00860VAS01  HU1039VA02 IE1100VA01 IL1043VA01 083006202101017 A5102671 A5163317 A5605732 A5105151 C5603903 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 XF0022 XF0149 YV0001 YV0002 YV0004 0850060718 0850060720 0850060721 0850060722 0850060725 850060707 KW1001VA03 KW1001VA04 KW1018VA04 KW1013VA01 LB1037VA01 MA1020VA01 BRD0411 NO1015VA04 600042VA02 787620IN4100 787653INNOVA 600152VA01 RU2714VA01 RU2992VA01 RU1050VA03 RU1018VA03 RU1106VA02 SA1005VA06 E001RX08 0002603739 0002603828 06004VAS02, and  853060187
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including 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; the United States territory of Puerto Rico; and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ,FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND,NORWAY, PANAMA, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI AR ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, and VENEZUELA.
  • Product Description
    GE Innova 4100 /4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) 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.
  • Manufacturer
    GE Medical Systems, LLC
Device Recall Innova 2000
  • Model / Serial
    00000424731BU8 00000416084BU2 00000423587BU5 00000415812BU7 00000418005BU5 00000393455BU1 00000397050BU6 00000419071BU6 00000423555BU2 00000422097BU6 00000423545BU3 00000409300BU1 00000389501BU8 00000398913BU4 00000395216BU5 00000423003BU3 00000415056BU1 00000420520BU9 00000418004BU8 00000419716BU6 00000400569BU0 00000423644BU4 00000423322BU7 00000405271BU8 00000392274BU7 00000400526BU0 00000404101BU8 00000399595BU8 00000392563BU3 00000424821BU7 00000422239BU4 00000403685BU1 00000403431BU0 00000397051BU4 00000403733BU9 00000409881BU0 00000382877BU9 00000420841BU9 00000415705BU3 00000407957BU0 00000387489BU8 00000418299BU4 00000393646BU5 00000393730BU7 00000397054BU8 00000424046BU1 00000399750BU9 00000404675BU1 00000405835BU0 00000409880BU2 00000419653BU1 00000407956BU2 00000397405BU2 00000402924BU5 00000394043BU4 00000419496BU5 00000413029BU0 00000419167BU2 00000408611BU2 00000397641BU2 00000400646BU6 00000420032BU5 00000417822BU4 00000418416BU4 00000424701BU1 00000422426BU7 00000395214BU0 00000397053BU0 00000392773BU8 00000420898BU9 00000388900BU3 00000407950BU5 00000397407BU8 00000389097BU7 00000389796BU4 00000389994BU5 00000397644BU6 00000397643BU8 00000394210BU9 00000390720BU1 00000418277BU0 00000424700BU3 00000421317BU9 00000389995BU2 00000424693BU0 00004093368BU8 00000399939BU8 00000392732BU4 00000399939BU8 00000424660BU9 00000416123BU8 00000397406BU0 00000391287BU0 00000416885BU2 00000420110BU9 00000411395BU7 00000411170BU4 00000401024BU5 00000413030BU8 00000394212BU5 00000421580BU2 00000426713BU4 00000423873BU9 00000411171BU2 00000404677BU7 00000407657BU6 00000406023BU2 00000406108BU1 00000395518BU4 00000400097BU2 00000437991BU3 00000425360BU5 00000412256BU0 00000417822BU4 00000426862BU9 00000436762BU9 00000437318BU9 00000432631BU0 00000423647BU7 00000415563BU6 00000404102BU6 00000402251BU3 00000392245BU7 00000426880BU1 00000409162BU5 00000392766BU2 00000440232BU7 00000440085BU9 00000391391BU0 00000393731BU5 00000421196BU7 00000400664BU9 00000401287BU8 00000418303BU4 00000423197BU3 00000395213BU2 00000424501BU5 00000388606BU6 00000418290BU3 00000407088BU4 00000426554BU2 00000425213BU6 00000394046BU7 00000416881BU1 00000424950BU4 00000402054BU1 00000422787BU2 00000415426BU6 00000418425BU5 00000427302BU5 00000402250BU5 00000426551BU8 00000419206BU8 00000427075BU7 00000417861BU2 00000417880BU2 00000412511BU8 00000419308BU2 00000407953BU9 00000410223BU2 00000398010BU9 00000420495BU4 00000410337BU0 00000397645BU3 00000419394BU2 00000418238BU2 00000388258BU6 00000393000BU5 00000422314BU5 00000410853BU6 00000417028BU8 00000421143BU9 00000405330BU2 00000415820BU0 00000390602BU1 00000404678BU5 00000421104BU1 00000416889BU4 00000397052BU2 00000399753BU3 00000408875BU3 00000424699BU7 00000410336BU2 00000393732BU3 00000423327BU6 00000403125BU8 00000387849BU3 00000437991BU3 00000398008BU3 00000415052BU0 00000392999BU9 00000392236BU6 00000400349BU7 00000416277BU2 00000415567BU7 00000395215BU7 00000403889BU9 00000424933BU0 00000419135BU9 00000404104BU2 00000415178BU3 00000399385BU4 00000403929BU3 00000407081BU9 00000403800BU6 00000425964BU4 00000404082BU0 00000404103BU4 00000410516BU9 00000395515BU0 00000423214BU6 00000408100BU6 00000409042BU9 00000409301BU9 00000426942BU9 00000424733BU4 00000390184BU0 00000397404BU5 00000398009BU1 00000395212BU4 00000421902BU8 00000389096BU9 00000421110BU8 00000418279BU6 00000401794BU3 00000445624BU0 00000410669BU6 00000403023BU5 00000446840BU1 00000417673BU1 00000416963BU7 00000399601BU4 00000391288BU8 00000392087BU3 00000424551BU0 00000400898BU3 00000420895BU5 00000400746BU4 00000403124BU1 00000419495BU7 00000411057BU3 00000395517BU6 00000419220BU9 00000418278BU8 00000392765BU4 00000425963BU6 00000422429BU1 00000418046BU9 00000410945BU0 00000382876BU1 00000409830BU7 00000425718BU4 00000446890BU6 00000413390BU6 00000415702BU0 00000426727BU4 00000418210BU1 00000395516BU8 00000416241BU8 00000402055BU8 00000393734BU9 00000421695BU8 00000411199BU3 00000423036BU3 00000416240BU0 00000399715BU2 00000393733BU1 00000425771BU3 00000420411BU1 00000405951BU5 00000387866BU7 00000425142BU7 00000417895BU0 00000404676BU9 00000422423BU4 00000425370BU4 00000416729BU2 00000418197BU0 00000416788BU8 00000422955BU5 00000416908BU2 00000426650BU8 00000409001BU5 00000422567BU8 00000422432BU5 00000417997BU4 00000417032BU0 00000410737BU1 00000406234BU5 00000367086BU6 00000392468BU5 00000407647BU7 00000419070BU8 00000417921BU4 00000421359BU1 00000417570BU9 UNK2252302-200 00000425360BU5 00000401211BU8 00000400097BU2 00000400151BU7 00000408597BU3 00000394213BU3 00000393185BU4 00000409163BU3 00000409827BU3 00000418415BU6 00000400186BU3 00000401600BU2 00000397642BU0 00000393647BU3 00000409155BU9 00000416563BU5 00000416671BU6 00000398011BU7 00000393186BU2 00000388459BU0 00000420104BU2 00000412931BU8 00000394045BU9 00000391181BU5 00000405374BU0 00000408840BU7 00000404430BU1 00000394211BU7 00000388087BU9 00000406580BU1 00000416632BU8 00000405768BU3 00000417594BU9 00000413030BU8 00000416580BU9 00000417599BU8 00000422771BU6 00000421701BU4 00000422469BU7 00000394209BU1 00000392580BU7 00000416864BU7 00000418000BU6 00000407955BU4 00000406792BU2 00000427204BU3 000000393456U9 00000406785BU6 00000394044BU2 00000408600BU5 00000421608BU1 00000411914BU5 00000423019BU9 00000398007BU5 00000389235BU3 00000397408BU6 00000387191BU0 and 00000403958BU2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV), TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS and AUSTRALIA.
  • Product Description
    GE, Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. || Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
  • Manufacturer
    GE Medical Systems, LLC
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