FDA · Medical device recall

Advantx-E is an angiographic X-Ray system and 5 more products

Sept. 16, 2008

Date posted by the FDA: Sept. 16, 2008
Status: Terminated
Filed by: GE Healthcare
Reason: 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
Distribution pattern: 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

6 products in this recall

Advantx-E is an angiographic X-Ray system

Product: Advantx-E is an angiographic X-Ray system.
Quantity: 252
Codes and lots: 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
Recall started: Jan. 14, 2008
Device type: System, X-Ray, Angiographic
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2038-2008

Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner…

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.
Quantity: 222
Codes and lots: 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…
Recall started: Jan. 14, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2039-2008

Innova 3100/3100IQ is a cardiovascular Imaging System…

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.
Quantity: 410
Codes and lots: 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…
Recall started: Jan. 14, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2040-2008

Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner…

Product: Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.
Quantity: 306
Codes and lots: 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 5135844100 719560INN41 303320OR41 303436ANGIO 3027444100 574294IN41 239939INNOVA 864255SF4100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 4134474100 5033704100 509474SH41 201541SP1 281401T4100 918744JR4100 22925941V2 SHOWCASE4100 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404GHSIR1 412647OR10 414649DVI 419696LAB1 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 570321LAB2 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 COR359867 DR4100 PEMBROKE4100 RADNETXV1 RHD4100 423495M4100E 423493I4100 8593134100 708WESTSUB4100 80140841 80180741 2194654100 4082594100 4105434100 4137484100 5094744100 5417684100 5703214100 5705224100 6082634100 7028804100 219326IN41 229228INNOV41C 22925941V 252816INNOVA 269226IN1 269226IN2 269983IN41 303839CL1 308534ANG 313876SP41 316651INNOVA41 317338PV3 360754INNOVA 401274IN41 412623LAB1 412623LAB3 414328INN4100 419251LAB1 508383IN4100 603650ANG1 608263ACT 608263XMR 617726RF2Y6 626359INNOVA 706291RINN 718206LIBERTY1 760633IR1 773878SWGANGIO1 801268INNOVA 804285CATH2 804764CATH3 810342A41 813558INTV 816943SP1 817433HSW4100 828298VASC 847842GS4100 856365ANGIO 903GS4100 904202SP1 904BSSP 952993INNOVA2 972335LIB 972566INNOVA3 985867INNOVA2 MIRAMAR41 WCATHLAB41 334286BSP 706278INNOVA1 561747IN4 252847PRS2 918744JC4100 850494WSP1 252816INNOVA 804594CATH 574535IN41 813745INTV 813972INTV 229228INNOV41V 508856OR41 717763INNOVA41 865541CCL5 SLIN4100 717763OR4100 239436CATH1 609652CATH3 80158241 216844INNOVA 77573841 727819SPSC ECXVINNOVARST3 404GHSIR2 989466INNOVA 404616INNOVA 352333VASC 812279INNOVA1 901726SP2 817255NH4100 828696IN41 304347INNOVA 918307SHIN4 724656ANG 757736INNOVA 315448RM4 941483INNOVA41 515263IL4100 4103374100 5138534100 8595724100 352401CATH 6029234100 5134754100 816276SP1 903CSM4100 319338VA4100 715369INN4100 407518SP3 956632INN4100 407518SP2 414961INN4100 904276SP 614293LIBERTY1 325670CATH 251435ICV5 315448RM5 573761SMA 3018774100 865693CCL3 614293LIBERTY2 229434INNOV 757398INNOVA 574647IN41 205759CL2 304255INNOVA 352401VASC 407SPECIALS 6012884100SP1 4438494100 740592INNOVA 804320CATH2B 478633INOV 8159374100 910063039 190020RX09 BG4037XR01 BE5005VA01 82406070010 82406310005 82416100016 82416130020 82416130021 82416130025 82416220006 82406120016 82416130010 82416130011 82416130013 82416160005 82406010011 82416130012 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA 416756INNOVA 519685INNOVA CS1054VA01 HC0220XR07 487692XR01 FI1015VA02 FI1015VA01 M1230007 00490VAS02 01278VAS01 10091VAS01 00137VAS01 00171VAS01 HU1039VA02…
Recall started: Jan. 14, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2041-2008

Innova 2000's principle system components include a C-arm…

Product: Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities.
Quantity: 388
Codes and lots: 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…
Recall started: Jan. 14, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2042-2008

Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System…

Product: Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane system with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures.
Quantity: 4 units
Codes and lots: ECXV1402B 4146492121 COR373252 N4192939
Recall started: Jan. 14, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Process control
What the company told customers: 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.
Recall number: Z-2043-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2038-2008, Z-2039-2008, Z-2040-2008, Z-2041-2008, Z-2042-2008, Z-2043-2008. The agency record governs; check it and the company before acting.

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