Recall of Device Recall Digital Fluoroscopic Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49524
  • Event Risk Class
    Class 2
  • Event Number
    Z-1475-2009
  • Event Initiated Date
    2008-06-17
  • Event Date Posted
    2009-06-19
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2014-10-22
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    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.
  • Action
    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.

Device

  • Model / Serial
     "9734293100aw, 9734293100, "903utaw31, 903ut3100", 870864lab2, 815599fhn3100, 630856h31, 678957innova, 0002676826x, 337374innova, 727521cathop, 720225cl2, 678957innova, 704355rm2, 609267in3100, 9287883100, 541743cl6, 405636isw3100, 575521cathb, 9284533100, 443481ep, 504447innova2, 931459cv1, 650723sc2, mcdcath2, 732776cath2, 812238lib1, 313593ic1, 650938ly31, 609597in3100, 853060194, 06074vas01, 34115vas02, 44009vas01, 01012vas01, 41018vas01, 58002vas01, 60001vas01, 34268vas01, sa1010va02, ru3053va01, ru1449va01, ru1102va02, ru1254va01, 600098va01, ru1482va02, ru1475va01, ru1142va01, ru2581va01, ru1457va01, ru2741va01, ru1692va01, ru1001va02, ru1913va02, ru3136va01, ru3137va01, ru3135va01, ru2886va01, pl1650va02, pl1688va01, pl1681va01, pl1640va01, pl1082va01, 600050va02, pl1491va01, 2048000innova, 2664627innova, 2685467innova, 2716439innova, 920169007, no1005va05, 834160003, 477xvin2553211, 52xvinn2565367, 818innovahm2, 0002714567b, lb1148va01, lb1003va01, kw1055va01, 850060719, 850060724, 850060726, 850060727, 850060728, yv0165, 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,=""  yv0164,=""  yv0052,=""  yv0168,=""  yv0167,=""  jo1000va01, a5718004, d5810520,=""  a5812258,=""  a5127281,=""  a5112597,=""  a5162256,=""  a5333035,=""  a5812244,=""  b5274834,=""  b5332001,=""  b5810907,=""  a5125119,=""  d5810520,=""  iq1165va01, ir1819va01, hu1099va04, h17654vas9, h4672vas02, ge1009va01, ge1005va01, ge1004va01, 01243vas03, 00203vas01, 01367vas02, 01243vas03, m2030709, m4163030, m4166988,=""  m5480755, m6083613, a6017504, m2848425, m4016034, m40480151, a9190149, m40480167, fi1064va01, mpx82206, fpg86403, fpg93008, dpm32143, dpn88402, fpa99414, 2655786innova, hc4348xr01, cs1006va03, 2625365innova, 2645993innova, 2735407innova, 82416220009, 82416190004, "82449120026, 082416120007, 82416160012, 82416210009, 82416130027, 82416040018, 82416140004, 82416290001, 82416140003, 82416130018, 82416080001, 82416010006, 82416020004, 82416020005, 82416030006, 82416040015, 82416040019, 82416100013, 82416110002, 82416110003, 82416120010, 82416140002, 82416150001, 82416160008, 82416160009, 82416160013, 82416180004, 82416190004, 82416190001, 82416190002, 82416190003, 82416210006, 82416210008, 82416220008, 82416270002, 82416300001, 82416310003, 82416310006, 82449100050, 82416160011, 82416170002, 82416030003, 82416030008, 82416030010, 82416100006, 82416100010, 82416100019, 82416120007, 82416120011, 82416130015, 82416160003, 82416160006, 82416210003, 82416210004, 82416310007, 82416220009, 82416130017, 82416030009, 82416120012, 82416180005, 82416310008, 82416040017, "82449030045,=""  (082416030006)", 82416150003, 82416130028, 82416150003, 82416150003, 82416130028, 82416130018, be5003va02="" (by4015va02), by4066va01, 2722671, 2722497, 2573329, 2676587, bg4549va02, 140024rx09, ba4080va01, 910064009, 910163012, 910163013, 910163015, 910064007, 910064008, 910162006, 910162008, 910163006, 910163007, 910163009, 378inv31, 4127inv31, tt-2586581-co, 818innovahm1, yv0167="" and 82416290002="" and;  serial="" 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, 00000519107bu7, 00000434370bu3, 00000497494bu5, 00000441211bu0, 00000444282bu8, 00000007c20319, 00000007c20105, 00000007c20109, 00000007c20088, 00000007c20050, 00000512702bu2, 00000489707bu0, 00000498672bu5, 00000520076bu1, 00000007c20065, 00000007c20225, 00000007c20135, 00000007c20015, 00000007c20173, 00000477866bu8, 00000513287bu3, 00000464108bu0, 00000464097bu5, 00000511691bu8, 00000477755bu3, 00000477787bu6, 00000477791bu8, 00000513175bu0, 00000477830bu4, 00000477834bu6, 00000498703bu8, 00000520073bu8, 00000007c20144, 00000519187bu9, 00000007c20059, 00000512703bu0, 00000099707ve2, 00000099789ve0, 00000450659bu8, 00000444299bu2, 00000453904bu5, 00000444331bu3, 00000464067bu8, 0000453944bu1, 00000464110bu6, 00000007c20266, 00000007c20203, 00000008c20048, 00000008c20057, 00000509188bu9, 00000007c20230, 00000007c20377, 00000007c20338, 00000464106bu4, 00000498681bu6, 00000007c20057, 00000526236bu5, 00000498697bu2, 00000489741bu9, 00000519185bu3, 00000489779bu9, 00000444313bu1, 00000007c20377, 00000532660bu8, 00000519122bu6, 00000498693bu1, 00000007c20325, 00000007c20185, 00000007c20256, 00000509199bu6, 00000520057bu1, 00000007c20390, 00000007c20096, 00000007c20116, 00000007c20390, 00000491248bu1, 00000464071bu0, 00000498674bu1, 00000498147bu8, 00000519153bu1, 00000007c20206, 00000444311bu5, 00000444263bu8, 00000438631bu4, 00000007c20304, 00000007c20311, 00000453943bu3, 00000519183bu8, 00000453924bu3, 00000499711bu0, 00000498682bu4, 00000498676bu6, 00000410867bu6, 00000520061bu3, 00000489750bu0, 00000441166bu6, 00000477833bu8, 00000489764bu1, 00000007c20395, 00000464070bu2, 00000513184bu2, 00000444310bu7, 00000519145bu7, 00000007c20242, 00000007c20202, 00000498886bu1, 00000007c20042, 00000519188bu7, 00000464089bu2, 000000mi002722, 00000464085bu0, 00000513189bu1, 00000511704bu9, 00000536798bu2, 00000498666bu7, 00000513529bu8, 00000489710bu4, 00000489708bu8, 00000489703bu9, 00000477823bu9, 00000464082bu7, 00000511694bu2, 00000453947bu4, 00000477794bu2, 00000477836bu1, 00000007c20045, 00000536793bu3, 00000513184bu2, 00000453914bu4, 00000511627bu2, 00000499695bu5, 00000464059bu5, 00000489732bu8, 00000464073bu6, 00000459701bu9, 00000513183bu4, 00000479561bu3, 00000477839bu5, 00000513182bu6, 00000519116bu8, 00000520082bu9, 00000479483bu0, 00000007c20011, 00000007c20177, 00000505115bu6, 00000453933bu4, 00000007c20080, 00000444310bu7, 00000007c20147, 00000444250bu5, 00000445632bu3, 00000441205bu2, 00000099664ve5, 00000453920bu1, 00000007c20026, 00000464070bu2, 00000467629bu2, 00000007c20145, 00000007c20257, 00000007c20155, 00000007c20129, 00000477777bu7, 00000498666bu7, 00000007c20381, 00000007c20254, 00000007c20381, 00000007c20381, 00000007c20254, 000000mi002722, 00000498706bu1, 00000007c20385, 00000007c20368, 00000008c20022, 00000513573bu6, 00000536812bu1, 00000007c20066, 00000007c20082, 00000519152bu3, 00000498888bu7, 00000499707bu8, 00000477807bu2, 00000519148bu1, 00000511646bu2, 00000441198bu9, 00000441200bu3, 00000444255bu4, 00000500006bu2, 00000444270bu3, 000000000atlas, 00000510179bu5, 00000007c20372, 00000469103bu6, 00000007c20354, 00000008c20057, 00000007c20238, 000000mi003340, 000000mi003749, 00000514117bu1, 00000514127bu0, 00000007c20284, 00000007c20295, 00000007c20317, 00000007c20318, 00000007c20371, 00000007c20391, 00000007c20402="" and 0000007c203516."="" v-b-tooltip=""> System ID Numbers:  388567772VASMET, 704384PHMCATH, 509946CATH2, 262687CL3, 318798CL1, 507385INN3100, 8189813100, 219877IN2 , 865512CL3, 704878CL31, 718250CATH1, 912486CATH1, DR3100, 417347FCV5, LVINOV4, 308865GIN2, 925779INNOVA408, 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, 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, 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 MARTINSVILLE310, 8185023100, 312STMNAZ3100, 630312B31,  717782INNOVA31B, 727725CATH2, 785354S3100,  918333JPIN2,  812450EP1, 316268INNOVAA, 717217INN31, 310825INNOVA31, 413540IN1, 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 M5480755, M6083613, A6017504, M2848425, M4016034, M40480151, A9190149, M40480167, FI1064VA01, MPX82206, FPG86403, FPG93008, DPM32143, DPN88402, FPA99414, 2655786INNOVA, HC4348XR01, CS1006VA03, 2625365INNOVA, 2645993INNOVA, 2735407INNOVA, 82416220009, 82416190004, "82449120026, 082416120007, 82416160012, 82416210009, 82416130027, 82416040018, 82416140004, 82416290001, 82416140003, 82416130018, 82416080001, 82416010006, 82416020004, 82416020005, 82416030006, 82416040015, 82416040019, 82416100013, 82416110002, 82416110003, 82416120010, 82416140002, 82416150001, 82416160008, 82416160009, 82416160013, 82416180004, 82416190004, 82416190001, 82416190002, 82416190003, 82416210006, 82416210008, 82416220008, 82416270002, 82416300001, 82416310003, 82416310006, 82449100050, 82416160011, 82416170002, 82416030003, 82416030008, 82416030010, 82416100006, 82416100010, 82416100019, 82416120007, 82416120011, 82416130015, 82416160003, 82416160006, 82416210003, 82416210004, 82416310007, 82416220009, 82416130017, 82416030009, 82416120012, 82416180005, 82416310008, 82416040017, "82449030045,  (082416030006)", 82416150003, 82416130028, 82416150003, 82416150003, 82416130028, 82416130018, BE5003VA02 (BY4015VA02), BY4066VA01, 2722671, 2722497, 2573329, 2676587, BG4549VA02, 140024RX09, BA4080VA01, 910064009, 910163012, 910163013, 910163015, 910064007, 910064008, 910162006, 910162008, 910163006, 910163007, 910163009, 378INV31, 4127INV31, TT-2586581-CO, 818INNOVAHM1, YV0167 and 82416290002 and;  Serial 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and 0000007C203516.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    GE Innova 3100 / 3100 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.
  • Manufacturer

Manufacturer

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