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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 2100IQ

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  Class 2 Device Recall Innova 2100IQ see related information
Date Initiated by Firm January 14, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-2039-2008
Recall Event ID 46796
510(K)Number K050489  K052157  K052412  K061163  
Product Classification Fluroscopic x-ray system - Product Code MQB
Product Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.
Code Information 2100 Q _ 505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 2035762100 214947MINNOVA 214947MINNOVA2 303839CL2 252384CATH1 303788CL1 4436432100 8184092100 219932DCL2 305364P2100 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 251435ICV3 239436CATH4 732776CATH4 212305CATH1 65049321 304424INNOVA 215453INNOVA21 229228INNOV21C RPINNOVA2100 303425CL3 317355INNOVA3 330363LAB3 330375LAB2 336538ARCL1 360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA 417347FCV4 501257VALAB1 508856IN21 516562INNOVA2A 518243LAB2 561548ET2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 610250INNOVA1 610250INNOVA3 612273INNOVA2 615284CV3 615342CV3 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 661327INNOVA2 713375U2100 717217INN21 717544GECATH2 717544GECATH3 718470EP 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN1 781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 815759CARDIAC1 817329BG2100 843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2 856853IN2100 858554INNOVA2 864255SFCL1 904597CATH 910343EP1 910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7 954987CCL8 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP 508335INNOVA 828213IN21 901765EP 262255INNOVA2 410337INNOVA6 573256MHC 804764CATH2 845365V13 847316INNOVA1 847316INNOVA2 910162009 910162010 910162011 910162012 910163011 910163014 010120RX44 82416100014 82416150002 82416100011 82416130026 82416010007 82416030005 82416040011 82416040012 82416040014 82416050003 82416060001 82416100009 82416100012 82416100017 82416120008 82416130016 82416130019 82416130023 82416130024 82416160007 82416180003 82416200004 82416210007 82416220010 82416120009 82416030004 82416100007 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 26814ANGI2 2664023INNOVA 2641225INNOVA CS1118VA03 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 HC4480XR05 HC1995XR03 DK1066VA02 DZ1006VA01 FEB52055 ME612436 CEE15663 C99999164 FI1017VA02 FI1017VA03 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 M4198195 M181374801 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 10507VAS01 H2077VAS27 H17654VAS8 828160007 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 HU1231VA10 835160017 835160018 IE1100VA02 IE1077VA01 IE1053VA01 8.3016E+12 8.3016E+13 8.30161E+13 8.30162E+13 8.30162E+13 8.30163E+13 8.30166E+13 8.30168E+13 8.30168E+13 8.30168E+13 8.30169E+13 8.30169E+13 8.30169E+13 8.30168E+13 IQ1126VA01 A5333036 A5333037 A147111802 A5125125 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 C5123625 C5123626 C5323515 B5603933 A5111034 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0077 YV0080 YV0055 YV0056 850060723 KW1018VA01 KW1018VA02 KW1018VA03 LV4000VA02 LV4000VA03 LV4001VA02 MA1004VA02 644INNOVA21 83INNOVA2588441 NO1009VA03 NO1064VA03 920169006 600151VA01 600042VA03 PL1677VA01 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 PER00218 RO1108XR01 SA1011VA01 SA1054VA02 A004RX01 A020RX13 847160003 SY1001VA02 SY2005VA01 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 35021VAS02 853060191   
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		 Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system
FDA Determined
Cause 2		 Process control
Action Consignees were contacted by means of a Urgent Medical Device Correction letter dated 1/14/07. The letter is addressed to; Hospital Administrator, Hospital Risk Management Department, Manger of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the affected product and safety issue. The letter offers recommendations, solutions and provides contact information. If you have questions contact the firm: In the US contact the call center at 800-437-1171, option 4 and other countries should contact your local GE Healthcare field service representative.
Quantity in Commerce 222
Distribution USA: AR, CA, CO, FL, GA, IL, IN, LA, MA, MD, MO, NC, NJ, NM, NV, OH OR, PA, SC, TN, TX, WI, AK, AL, AR, AZ, CT, DE, GA, HI, IA, ID, KS, KY,LA ME, MI, MN, MS, MT, ND, NE, NH, NY, OK, RI, UT, VA, WA, WI, WV. OUSA: Hungary Algeria Argentina Australia Austria Belarus Belgium Bosnia Brazil Bulgaria Canada Chile China Columbia Czech Republic Denmark Egypt Finland France Georgia Germany Greece Guadeloupe Guatemala Honduras Hong Kong India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Kuwait Latvia Lebanon Malaysia Malta Mexico Morocco Netherlands New Zealand Nigeria Norway Pakistan Panama Poland Portugal Puerto Rico Romania Russian Federation Saudi Arabia Singapore Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom Uruguay Venezuela Yugoslavia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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