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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 3100/3100IQ

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  Class 2 Device Recall Innova 3100/3100IQ 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-2040-2008
Recall Event ID 46796
510(K)Number K031637  K052157  K052412  K061163  
Product Classification Fluroscopic x-ray system - Product Code MQB
Product Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.
Code Information 215576INNOVA1 760242CATH1 281420LAB23100 541382CV3 205783BCL5 2035763100 843797TCL2 361980INNOVA2 214590PH3100 303629CL4 303629EP 3027443100 303788CL2 239939CLA 8184093100 919731WMINOV 305364P3100 281440CL3 208227CATH2 7028533100 865693CCL1 6619483100 219326IN31 7022333100 209334LINNOVA1 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 8508573100 850469BCV1 207662CL4 207879CL131 541677MINNOVA1 5033703100 253968INNOVA 412437INNOVA 303425CL4 2595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 631968INNOVA2 631968INNOVA3 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 480728LAB2 865481CCL2 8157413100 251633PROV 907562CATH1 201996LAB1 207351YCL1 281420LAB1 412623LAB2 480821IN2 508856IN2 541MWHINNOVA 573882UMC1 610447CL1 610891CL1 617789IN1 706774CCL4 706774CCL5 713776M3100 717782INNOVA31 803256PCL1 812450CATH1 815226INN2 918494IN31A 952993INNOVA5 BPINNOVA1 845365V19 918333JPIN1 909788INNOVA1 516663INNOVA2 312STMNAZ3100 518525LAB1 540953INNOVA 717217INN31 573815BCR1 313593IC2 561266IN31 812450EP1 808547QCV2A 765453INNOVA1 413447CATH 770991CL3 417269SCLD 619340VA8 928779INNOVA1 713794LAB9 313593IC1 713794LAB7 956389INN31 316268INNOVAA 732294INOV 318448INNOVA2 318449INNOVA2 602239LAB4 7028803100A 310423INNOVA1 602239LAB6 812482INNOVA 702616INNOVA 724773C1 502587LAB4 973971LAB3 4103323100 214324INNOVA2 619482INNOVA1 BPINNOVA2 602266LAB2 956994INN1 773792CL3100 314768SMCL3 812238LIB1 812283IN31 FHORLCL1 409899LAB3 936266CL1 8613100 563421CATHLAB8 309691P3100 956994INN2 817433HSW3100 803329CL31 413540IN1 601553CL3 608524NOVA 850678IN3100 714966INNOVA 7083333100 619541INNOVA31 904202CATH3 615769SKYCV2 201541LAB2 615338CV2 718283INNOVA3 773NORWG3100 5034353100 4103623100 8019643100 7278253100 505662NOVA 378INV31 AH4300XR03 910064009 910163012 910163013 910163015 910064007 910064008 910162006 910162008 910163006 910163007 910163009 BA4080VA01 140024RX09 2573329 BE5003VA02 82416040018 82416290001 82416140003 82416130018 82416080001 82416010006 82416020004 82416030006 82416040015 82416040019 82416100013 82416110003 82416120010 82416140002 82416150001 82416160008 82416160009 82416190004 82416190001 82416190002 82416190003 82416210006 82416210008 82416220008 82416270002 82416300001 82416310003 82416310006 82416170002 82416030003 82416100006 82416100010 82416120007 82416130015 82416160006 82416210003 82416210004 82416220009 82416130017 82416040016 82416070004 82416070003 82416040010 82416100008 82416120006 82416120005 82416050002 82416040017 2625365INNOVA 2645993INNOVA CS1006VA03 HC4348XR01 HC1536XR04 DK1066VA01 FPG86403 FPG93008 DPM32143 DPN88402 FI1064VA01 M2030709 M4163030 M4166988 M5480755 M6083613 M2848425 M2970614 M4016034 M40480151 A9190149 M40480167 GE1005VA01 GE1004VA01 H1420VAS04 24516572980IN HU1099VA04 IQ1083VA01 IR1747VA01 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 A5125119 A5108239 A5203215 JO1000VA01 YV0048 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0023 YV0024 YV0025 YV0027 YV0028 YV0029 YV0030 YV0031 YV0032 YV0037 YV0036 YV0026 YV0022 850060719 850060724 850060726 850060727 850060728 LB1160XR07 LV4012VA01 52XVINN2565367 477XVIN2553211 834160003 NO1005VA05 920169007 2048000INNOVA PL1082VA01 PL1622VA01 600050VA02 PL1681VA01 PL1688VA01 600098VA01 RU1482VA02 RU1142VA01 RU2581VA01 RU2457VA01 RU1550VA01 RU1156VA01 RU1449VA01 RU1457VA01 RU3092VA01 RU1692VA01 RU2741VA01 RU1001VA02 600130VA01 SA1010VA02 TN1016VA01 01012VAS01 41018VAS01 58002VAS01 60001VAS01 06074VAS01 853060194 388567772VASMET 3882569347VAMET 
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 410
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
510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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