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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 2000

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  Class 2 Device Recall Innova 2000 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-2042-2008
Recall Event ID 46796
510(K)Number K024200  
Product Classification Fluroscopic x-ray system - Product Code MQB
Product Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.
Code Information 2000- ECXV1406C 812450CATH2 256880IN1 508856IN4 615316INOV2 610988INNOVA1 310540INNOVA 210297NECATH1 314966DCL2A 213977INNOVA1 650696INV1 865541CCL2 415206CATH 609653INNOVA 732776CATH5 985867INNOVA1 615327CV2 FHORLCL6 315448RM3 573472CATH 315448RM1 315448RM2 865541CCL1 318448INNOVA 636916SPCL1 410543CATH6 606439INNOVA 801373EP 423495CHIRM1 316268INNOVAEP 973971LAB1 440835INNOVA 801373CATH1 718780CATH1 801373CATH2 AL9INNOVAVAN 865481CCL1 518525LAB2 708425INNOVA1 408259INV 610270INNOVA 207795CL2 619260INNOVA 516663INNOVA1 860210CV 610954INNOVA2 717270INNOVA1 803329CL20 920288CATH2 865693CCL5 702731INNOVA2 601553CL2 831624INV1 936266CL2 775982CATH3 832355SMIN 713897CIN 636947JCL3 861EP2 717544CATH4 407518OPCL 330375LAB1 801429INNOVA 701234GE2 701234GE3 610988INNOVA3 918494IN2A 920015947 219947EP 336832MCCL1 DR2000 ECXV1401A 773878WCL 217258CATH MCTHSC2 717763INNOVA2 713776MINNOVA 508798INC2 626915INNOVA 920288CATH1 615222STCL3 540932INNOVA 541282CV1 361788NOVA 727825CATH 262243INNOVA1 352344CATH1 414291CL3 FHVIN2000 817255NH2000 410614CV7 719560HCL2 603668CLCB 352INVCATH 512341RI 219465CL1 612467INNOVA1 602239LAB1 918307SHIN1 619739INNOVA 918307SHIN2 805497INNOVA1 513559INNOVA 414219INNOVA 707546INNOVA 940384INNOVA2 573632CRC1 904202CATH1 206598INNOVA1 972540INN 972335INN 405272SCL4 615284CV2 312792RINOV2 480512IN1 423844CCL2 516562INNOVA5 309691HCL1 502587LAB3 229259INOV2 718226INNOVA1 904202CATH2 219465EP 619457INNOVA3 843692INNO 843674INNOVA 401274IN3 419227CL3 619691INNOVA 940764INOV1 940764INOV3 563421CATHLAB7 513861INNOVA 614293INNOVA3 561798CL1 208381INNOVA 212746J412 816932HRT2 803256PEP1 940764INOV2 623848LAB1 415750SCL2 WCATHLAB2000 KMCINNOVA 817922INNOVA 205783BCL4 330837INNOVA 570969CATH 615327CV1 727521CATH3 773STJINNOVA200 619340VA7 601268INNOVA1 512447SI2 256386IN1 407321INCL1 773878SWGCATH1 615222STCL5 503215INNOVA 281351TINNOVA 920926CATH1 903798WINN 209526ICATH1 805497INNOVA2 717270INNOVA2 717544CATH1 215728INNOVA 773878SWGCATH2 732776CATH1 573761SMC1 760633INNOVA 239436CATH2 973971EP2 412647LABA 859233INNOVA2 610988INNOVA2 412647LABB 812283IN20 908668INNOVA 724773C2 718918CATH1 443849INNOVA 610447CL2 708202VA2K 856342INNOVA 952993INNOVA4 952993INNOVA3 859233INNOVA1 814534C1 719776EP1 281893INNOVA 502587LAB5 317621EP2 478765CTH2 718963INNOVA1 718226INNOVA2 708597EP 478765CTH1 910162005 910163008 0910162004A 910163010 910163004 1157760 BE5006VA01 82416100005 82416120002 82416130009 82416220005 82416220004 82416220007 82406140020 82416210002 82416040008 82416030002 82416010004 82416160004 82416040013 82416210005 82416200006 82416040007 82416120003 82416120004 82416050001 82416310005 82416310004 613548INNOVA2 905895INNOVA1 514843AINNOVA 819563CINNOVA2 514376CARDIO 604682INNOVA 905895INNOVA2 905895INNOVA3 266150XR14 2575962INNOVA HC1536XR02 HC5533XR08 HC1627XR20 HC5546XR09 UC3287XR05 HC3285XR06 HC3121XR01 DZ1027VA01 EG1003VA01 EG1524VA01 ME256638 DE203229 FE421134 FEE08424 FEE12418 M2030707 E4167627 M4163751 M2147243 M2569312 M2002611 A9793302 X100378801 M2208714 S4160056 X76305701 B4498640 B4498642 M4046541 M4159626 M1327506 01224VAS02 00577VAS04 00159VAS03 00577VAS03 10238VAS01 00391VAS01 10044VAS01 00463VAS05 01245VAS01 10100VAS05 00162VAS03 10100VAS04 01224VAS03 00171VAS02 00285VAS03 00285VAS02 00490VAS01 00327VAS01 00506VAS01 10086VAS03 00424VAS01 00285VAS01 10501VAS01 00529VAS01 H2015VAS15 H2009VAS17 828060057 HU1044VA01 835160015 835160019 IE1018VA02 IE1029VA01 IE1031VA04 IE1006VA01 IL1098XR02 8.30168E+13 8.30168E+13 8.30162E+13 8.3016E+13 8.30162E+13 8.30168E+13 8.30161E+13 8.30168E+13 8.30162E+13 8.30168E+13 8.30168E+13 8.30166E+13 8.30162E+13 8.30168E+13 8.30166E+13 8.30168E+13 8.30166E+13 8.3016E+13 8.30168E+13 IR1632VA03 IR1667VA01 A5113511 A5189713 A5807006 A5203209 A5108714 A51152101 A5130609 A5108235 A5129951 A5129954 A5359404 A5129022 C5343110 A5129953 B5418905 A5730901 YX1487 YX1486 YX1492 YXZ471 YX1493 YX1494 YX1491 850060711 850060715 850060709 850060708 850060710 850060712 850060713 850060714 850060717 LB1050VA02 LWD0302 NO1064VA01 PK1251VA01 PL1101VA02 PL1008VA01 PL1529VA01 809840INNOVA 809852INNOVA RU1070VA01 600107VA01 RU1016VA01 RU1463VA01 RU1717VA01 RU2167VA01 SA1054VA01 SA2045VA01 SY1007VA01 SY2011VA01 856160001 856160003 856160004 856160005 TN1194VA01 TN1012VA01 TN1059VA01 07010VAS01 06070VAS01 16016VAS01 853060179 388558268VASAND 388256938VASMET 3882591464VAMET  
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 388
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 MEDICAL SYSTEMS, INC.
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