Events

Recall of Device Recall Innova 2100IQ

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
    49539
  • Event Risk Class
    Class 2
  • Event Number
    Z-0473-2009
  • Event Initiated Date
    2008-01-30
  • Event Date Posted
    2009-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73761
  • 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
    Image-intensified fluoroscopic x-ray system - Product Code MQB
  • Reason
    Software error, computer: ge healthcare has became aware of an issue with error management affecting the innova 2100, 3100/3100 iq & 4100/4100iq. it was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no x-rays being emitted. but the message "acquisition in progress" was displayed on the dl monitor, even after the foot switch was r.
  • Action
    Consignees sent a "GE Urgent Medical Device Correction" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894

Device

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

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