Devices

GE Innova 2100IQ

  • Model / Serial
    Serial Numbers: 00000549014BU9 00000559113BU6 00000468132BU6 00000550787BU6 00000476562BU4 00000504278BU3 00000541267BU1 00000504213BU0 00000543793BU4 00000471654BU4 00000493726BU4 00000484054BU2 00000480361BU5 00000491716BU7 00000480141BU1 00000478109BU2 00000551073BU0 00000542139BU1 00000548596BU6 00000568569BU8 00000492255BU5 00000548503BU2 00000545486BU3 00000552387BU3 00000485315BU6 00000558901BU5 00000466659BU0 00000470059BU7 00000466984BU2 00000572055BU2 00000505180BU0 00000499524BU7 00000473103BU0 00000544810BU5 00000566379BU4 00000566835BU5 00000499523BU9 00000500515BU0 00000571259BU1 00000472240BU1 00000499386BU1 00000559819BU8 00000551081BU3 00000484361BU1 00000564503BU1 00000549262BU4 00000551080BU5 00000520192BU6 00000490443BU9 00000476249BU8 00000461599BU3 00000533867BU8 00000537820BU3 00000054776BU4 00000548841BU6 00000543266BU1 00000551641BU4 00000512954BU9 00000493888BU2 00000518354BU6 00000553078BU1 00000469582BU1 00000545962BU3 00000485032BU7 00000566594BU8 00000468193BU8 00000570102BU4 00000569024BU3 00000545490BU5 00000543797BU5 00000509365BU3 00000560479BU8 00000479585BU2 00000548595BU8 00000543796BU7 00000531109BU7 00000552382BU4 00000460641BU4 00000460969BU9 00000550786BU8 00000504275BU9 00000493887BU4 00000563630BU3 00000552746BU0 00000563628BU7 00000531111BU3 00000569371BU8 00000513959BU7 00000466830BU7 00000473099BU0 00000479758BU5 00000479243BU8 00000477389BU1 00000500616BU8 00000509440BU4 00000566146BU7 00000491709BU2 00000543076BU4 00000546168BU6 00000561529BU9 00000509441BU2 00000491706BU8 00000562976BU1 00000553276BU7 00000477893BU2 00000546167BU8 00000560911BU0 00000515486BU9 00000537597BU7 00000564215BU2 00000538055BU5 00000493727BU2 00000562518BU1 00000508010BU6 00000559585BU5 00000560474BU9 00000552390BU7 00000483161BU6 00000559233BU2 00000479216BU4 00000465375BU4 00000483162BU4 000000006U0007 00000533870BU2 00000552055BU6 00000556787BU0 00000500612BU7 00000567993BU1 00000569026BU8 00000567352BU0 00000567338BU9 00000509439BU6 00000464559BU4 00000463841BU7 00000479937BU5 00000499840BU7 00000567334BU8 00000493725BU6 00000544289BU2 00000560909BU4 00000552385BU7 00000469466BU7 00000543169BU7 00000542273BU8 00000467455BU2 00000492106BU0 00000546157BU9 00000492922BU0 00000567350BU4 00000552386BU5 00000565106BU2 00000517924BU7 00000547292BU3 00000538034BU0 00000513294BU9 00000471760BU9 00000548165BU0 00000471487BU9 00000468168BU0 00000476109BU4 00000523240BU0 00000461379BU0 00000542138BU3 00000478363BU5 00000504277BU5 00000480315BU1 00000480140BU3 00000479701BU5 00000476013BU8 00000492457BU7 00000513296BU4 00000538053BU0 00000545052BU3 00000541271BU3 00000477463BU4 00000511494BU7 00000548592BU5 00000551634BU9 00000468192BU0 00000469465BU9 00000470060BU5 00000545048BU1 00000523777BU1 00000545046BU5 00000461266BU9 00000523086BU7 00000516769BU7 00000538572BU9 00000537027BU5 00000540176BU5 00000553269BU2 00000491032BU9 00000543265BU3 00000543798BU3 00000548598BU2 00000540174BU0 00000544495BU5 00000542274BU6 00000510844BU4 00000541966BU8 00000476725BU7 00000492136BU7 00000569021BU9 00000513958BU9 00000530413BU4 00000549261BU6 00000543799BU1 00000560472BU3 00000478275BU1 00000492243BU1 00000476685BU3 00000545588BU6 00000465560BU1 00000543269BU5 00000509136BU8 00000537449BU1 00000523241BU8 00000491172BU3 00000551444BU3 00000522942BU2 00000564216BU0 00000008C20126 00000565614BU5 00000563636BU0 00000551443BU5 and 00000545589BU4.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- United States including Puerto Rico and Guam.
  • 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). || 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 Healthcare
  • 1 Event

Manufacturer

Ge Healthcare
  • Manufacturer Address
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall GE Innova 2100IQ
  • Model / Serial
    00000459256BU4, 00000459553BU4, 00000459554BU2, 00000459555BU9, 00000459556BU7, 00000459557BU5, 00000460056BU5, 00000460057BU3, 00000460058BU1, 00000460059BU9, 00000460060BU7, 00000460063BU1, 00000460065BU6, 00000460066BU4, 00000460067BU2, 00000461642BU1, 00000461643BU9, 00000461644BU7, 00000461645BU4, 00000462898BU8, 00000462899BU6, 00000462900BU2, 00000462901BU0, 00000462902BU8, 00000462903BU6, 00000462904BU4, 00000462905BU1, 00000462906BU9, 00000462907BU7, 00000463613BU2, 00000463630BU4, 00000463631BU2, 00000463632BU0, 00000463633BU8, 00000463634BU6, 00000463636BU1, 00000463637BU9, 00000463638BU7, 00000463639BU5, 00000463841BU7, 00000467440BU4, 00000467441BU2, 00000467442BU0, 00000467443BU8, 00000467444BU6, 00000467445BU3, 00000467446BU1, 00000467447BU9, 00000467448BU7, 00000467449BU5, 00000467451BU1, 00000469541BU7, 00000469542BU5, 00000469543BU3, 00000469544BU1, 00000469545BU6, 00000469546BU6, 00000469547BU4, 00000469548BU2, 00000469549BU0, 00000469550BU8, 00000470643BU8, 00000470644BU6, 00000470645BU3, 00000470646BU1, 00000470647BU9, 00000470648BU7, 00000470649BU5, 00000470650BU3, 00000470651BU1, 00000470652BU9, 00000471493BU7, 00000471494BU5, 00000471495BU2, 00000471496BU0, 00000471497BU8, 00000471498BU6, 00000471499BU4, 00000471500BU9, 00000471501BU7, 00000471502BU5, 00000472676BU6, 00000477489BU9, 00000477490BU7, 00000477491BU5, 00000477492BU3, 00000477493BU1, 00000477494BU9, 00000477495BU6, 00000477496BU4, 00000477497BU2, 00000477498BU0, 00000477893BU2, 00000479230BU5, 00000479231BU3, 00000479232BU1, 00000479233BU9, 00000479234BU7, 00000479235BU4, 00000479236BU2, 00000479237BU0, 00000479238BU8, 00000479239BU6, 00000479937BU5, 00000479945BU8, 00000479946BU6, 00000479947BU4, 00000479948BU2, 00000479949BU0, 00000479950BU8, 00000479951BU6, 00000479952BU4, 00000479953BU2, 00000479954BU0, 00000482511BU3, 00000482512BU1, 00000482513BU9, 00000482514BU7, 00000482515BU4, 00000482516BU2, 00000482517BU0, 00000482518BU8, 00000482519BU6, 00000482520BU4, 00000484054BU2, 00000485072BU3, 00000485074BU9, 00000485075BU6, 00000485076BU4, 00000485077BU2, 00000485078BU0, 00000485079BU8, 00000485080BU6, 00000485081BU4, 00000487465BU7, 00000487466BU5, 00000487469BU9, 00000487470BU7, 00000487471BU5, 00000487472BU3, 00000487473BU1, 00000487474BU9, 00000491019BU6, 00000491020BU4, 00000491021BU2, 00000491022BU0, 00000491023BU8, 00000491025BU3, 00000491027BU9, 00000491028BU7, 00000491032BU9, 00000492823BU0, 00000492824BU8, 00000492825BU5, 00000492827BU1, 00000492828BU9, 00000492830BU5, 00000492831BU3, 00000494960BU8, 00000504480BU5, 00000508755BU6, 00004600057BU3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, and United Kingdom.
  • Product Description
    GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.
  • Manufacturer
    GE Healthcare
Device Recall GE Innova 2100IQ Fluroscopic xray system
  • Model / Serial
    201447LAB1 202782LABC 2035762100 208227CATH1 208367INNOVA 208381CCL1 212305CATH1 212604INNOVA1 214947MINNOVA 214947MINNOVA2 215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3 251435ICV7 252384CATH1 253627INNOVA1 262255INNOVA2 262255INNOVA2 262687CL2 303369HCL4 303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1 310825INNOVA21 317355INNOVA3 318448INNOVA3 330363LAB3 330375LAB2 336538ARCL 336832MCCL6 360456XCL4 402559UCC 402559UCD 405604D2100 408559INV1 409938INV21 410337INNOVA6 410554INNOVA1 410554INNOVA2 410554INNOVA3 410554INNOVA4 4107872100 412367LAB2 414291CL2 414649INNOVA2 416480INNOVA 416864INNOVA 416864INNOVA2 417269SCLA 417347FCV2 417347FCV4 423495MCATH1 4436432100 501257VALAB1 505848CATH1 505848EP 508335INNOVA 508856IN21 508941IN21 509575YM2100 516562INNOVA2A 516562INNOVA6 516562INNOVA7 516632INNOVA1 518243LAB1 518243LAB2 541732CV2 541743CL3 561548ET2 570476INNOVA21 573256MHC 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 604682INNOVA1 604682INNOVA2 604875AINNOVA1 604875AINNOVA2 607737CL1 608775NOVA1 608775NOVA2 610250INNOVA1 610250INNOVA3 610776INNOVA21 610983INNOVA2 612273INNOVA2 615284CV3 615342CV3 615446CV1 615515OPCL 617636CL1 619457INNOVA6 619552INNOVA2 630856H2100 650369SV4 65049321 651582IN3 661327INNOVA1 661327INNOVA2 7023602100 704384CL21 706291CLIN1 713375U2100 713794LAB1 717217INN21 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727521CATH2 727521CATHOP 727869CATH3 727869CCL2 727869EP5 727942CATH2 732324INN1 732776CATH4 732923INN 770HMCCL1 775982INN2100 781340IN1 781340IN3 785354HRTEP 803256PCL5 804764CATH2 8053702100 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 8157412100 815759CARDIAC1 816861KCVAI2 817329BG2100 8184092100 828213IN21 843692CATH3 843724CL1 843724CL2 843724CL3 843724EP1 843797EP 843797TCL1 845365V13 845368LAB1 845368LAB2 847316INNOVA1 847316INNOVA2 856853IN2100 857307IN421 858554INNOVA2 858554INNOVA3 864255SFCL1 864255SFCL2 865693CCL 865693CCL2 865977CCL 901765EP 904597CATH 905848INNOVA1 910343EP1 910343EP2 910671INOV21 916781INNOVA2 9284532100 937208INNOVA2 949250I21 954735CL2 954987CCL7 954987CCL8 954987CL4 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP LVINOV7 PRESBYDEP RPINNOVA2100 2637041 2680771 2683172 2686112 2706718 2710562 2713664 2713687 2715023 2718602 2729712 2730402 2730405 2730406 2731313 2731570 2731573 2731583 2738012 2741780 2749861 2754702 2755150 2756171 262687CL1 316689MP 541677MINNOVA2 541789CV1 609267IN2100 609757IN2100 610645LAB10 760940INNOVA2, and 828315FIN2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and GUAM.
  • Product Description
    Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
  • Manufacturer
    GE Healthcare