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U.S. Department of Health and Human Services

Class 2 Device Recall AdvantxE

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  Class 2 Device Recall AdvantxE 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-2038-2008
Recall Event ID 46796
510(K)Number K945375  K960575  K974367  
Product Classification Fluroscopic x-ray system - Product Code IZI
Product Advantx-E is an angiographic X-Ray system.
Code Information 206598LCBI 215955LCLP 304843LCA 309655FSP4 312942EP1 318377MC1XX 405840SOIC 409772VAS5 505887CL1 507225CC101 516663EP2 574294LCA 602532LCA 609653LCA 609757CCL5 609757EP1 609757LCEP 610988EP 615443LCA 650369SV2 702731LCPLUS 706774UEP1 714670LCA 717544EP8 717763EP1 717782EP1 757398EP 760241LCV 772468LCA 773564LCA 781769NCL 818884LCA 864560SPLCA 936266LCA 954MWLCA 956994BICATH BPANGIO ECXV1407CLCV ECXV1407ELCV ECXV1407ILC OLC-ADVE VASCSOUTH 309655FSP2A 501978LAB2 918307CDLC 810326LCA 918307SHLC1 410614CV6 314525ACL1A 904739EP 843797LCA2 603669ELCV 703689LCA2 301896ANGIO2 361788LCPLUS 915670LCA 612273LCLP 617636EP BPEP 770844NFLCA 281420LAB2 918744JB5 215750LCLP 410543CATH3 904202EPA 504785LCA 303839CL4 856342LCLP 717544EP7 213977LCLP1 314768SMOL1 215823LCLP BG4549VA01 4406 2584562 1165109 082406030007T 82406030011 82406040023 82406040024 82406050008 82406050009 82406060002 82406070009 82406070011 82406090011 82406090012 82406090014 82406090015 82406090017 82406090021 82406100012 82406100013 82406100015 82406100017 82406110001 82406110003 82406120015 82406130015 82406130016 82406130017 82406140018 82406160036 82406160037 82406160038 82406160041 82406180003 82406190009 82406190011 82406190012 82406190013 82406200003 82406230009 82406230011 82406230012 82406270006 82406290001 82406300001 82406310002 82406532603 082406ATCLCV1 82406030012 82406120017 82406100014 82406020003 82406100016 82406140019 82406310004 82406090018 82406090020 82406090016 82406090019 82406040026 82406140021 82406010012 82406130018 82406060003 82406270007 519663LCP 519685LCNP 416369LCLP 514398BIPLAN CS1118VA02 UC1923XR23 EG1235VA01 EG1703VA01 FP721A02 DPN85900 YE162A29 NE185034 YE645824 YP158312 A1105902 A4160425 A9793301 M2002604 M2528706 M4212427 X2881402 A1064503 A1105901 M1076843 B1607012 M4488827 A9793306 00440VAS01 GE1006VA01 GP1046VA01 2546301ADLCV 835060023 8.30066E+13 8.3016E+12 8.30166E+12 8.30166E+13 8.30166E+13 8.30166E+13 8.30166E+13 8.30168E+13 8.30168E+13 8.30166E+13 8.3006E+13 A5375115 A5719806 A5114287 A5267808 A5687002 B5381808 A5719814 A5129811 A5332104 C5821416 YX1512 YX1513 YX1525 YX1675 YX1678 YX1681 YX1700 YX1516 YX1530 YX2222 KW1001VA02 KA1048VA01 LB1018VA01 LB1188VA01 MA1274VA01 MA1361VA01 MA1276VA01 MA1272VA01 MA1205VA01 MA1288VA01 MA1312VA01 MA1174VA01 MT1014VA01 2504649LC+ 33XVLCN544793 6622LCDLX 9926LCPLUS NG1018VA01 RTD1205 RO4165VA01 RU1047VA01 RU1086VA03 RU1175VA01 RU1379VA01 RU2076VA01 RU2400VA01 RU2580VA01 RU1205VA01 SY2035VA01 SY2026RX01 06092VAS01 34004VAS01 34107VAS01 65005VAS01 78001VAS01 01002VAS02 853060178 853060181 853060182 853060183 853060184 853060185 853060186 853060190 853060180 853060188 853060189 853060192 5982LCV 388555220VASMET YU4060VA01 
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 252
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 = IZI and Original Applicant = GE MEDICAL SYSTEMS
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