FDA · Medical device recall

Innova 2000… and 3 more products

Sept. 20, 2008

Date posted by the FDA: Sept. 20, 2008
Status: Terminated
Filed by: GE Healthcare
Reason: The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.
Distribution pattern: Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and GUAM.

4 products in this recall

Innova 2000…

Product: Innova 2000; The principle system components include a C-arm, image acquisition, processing and archiving capabilities. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
Quantity: 591
Codes and lots: 201996LAB2 201996LAB3 202745VACATH2 202745VACATH2 203576NI1 205783BCL3 205783BCL4 206598INNOVA1 207626CL1 207755CL1 207795CL1 207795CL2 207871CL6 208381INNOVA 208523CATH 209526ICATH1 210292CATH1 210297NECATH1 212746J412 213726CATH 213977INNOVA1 213977INNOVA4 214320INNOVA 214590INNOVA 214820INNOVA3 214820INNOVA4 214947CMINNOVA 215448INNOVA 215728INNOVA 215861LC2 216778LABA 217258CATH 217383CCL3A 217464INNOVA 219465CL1 219465EP 219757INVA 219932DCL1 219947EP 228INNOVA 229259INOV1 229259INOV2 229386INOV1 239436CATH2 239939CLB 251435ICV1 251435ICV1 251435ICV4 252443NGIN1 253627INNOVA2 253627INNOVA3 254519I2K 256341IN1 256386IN1 256880IN1 262243INNOVA1 262255INNOVA1 262569INNOVA 281338INA 281351TINNOVA 281440LAB2 281440LAB3 281540NECATH 281893INNOVA 301891CATH1 302421INNOVA 303320CL1 303320CL2 303369CL2 303425HCL1 303673CL1 303715CL1 303730CL1 303778CL1 303778CL2 305223IN1 305223IN2 305325CCL3 305325CL4 305585CL2 305585CL3 308865PHI 309454BINNOVA 309691HCL1 309691PINNOVA 310423INNOVA3 310423INNOVA4 310423INNOVA5 310423INNOVA7 310540INNOVA 312792RINOV2 313343LC 314569JC1 314966DCL2A 315448RM1 315448RM2 315448RM3 316268INNOVAB 316268INNOVAEP 316689INNOVA1 317621EP2 317621INNOVA1 317621INNOVA1 317621INNOVA2 317621INNOVA2 317621INNOVA3 317621INNOVA3 317818MDI915 317887INNOVA1 317887INNOVA2 318448INNOVA 318449INNOVA1 321HCL4 321HCL5 321PBCL1 330375LAB1 330837INNOVA 336716BCL1 336832MCCL1 336832MCCL3 337289INNOVA 352344CATH1 352INVCATH 361788NOVA 386719CATH 401274IN3 402280CIN1 402280CIN2 404265AMC2 404305SF1 404686CRI1 404686CRI2 404712EI1 405272SCL4 407321INCL1 407518CL1 407518OPCL 408259INV 410337INNOVA1 410337INNOVA3 410337INNOVA4 410337INNOVA5 410543CATH1 410543CATH6 410614CV7 412232B 412367LAB1 412367LAB3 412623LABB 412623LABB 412623LABC 412623LABI 412647LABA 412647LABB 412647LABC 412647LABC 412647LABD 412784C1 413748INNOVA 414219INNOVA 414291CL3 414649INNOVA 414805INNOVA2 414961INNOVA 415206CATH 415750SCL1 415750SCL2 416284INNOVA 416469INNOVA 417269SCLB 417269SCLC 417885JCL1 417885JCL2 417885JCL3 417885JCL4 418656CNOVA1 418656CNOVA2 419227CL3 419526INNOVA3 419526INNOVA4 423493PCL3 423495CHIRM1 423559BCL1 423844CCL2 440835INNOVA 443481INOVA1 443849INNOVA 478765CTH1 478765CTH2 480512IN1 480512IN3 480728LAB1 480821IN1 501484LC3 501686UAINNOVA 502587L2 502587LAB3 502587LAB5 503215INNOVA 503370INNOVA 504391INNOVA 504447INNOVA 504903INNOVA 505983CATH 508798INC2 508856IN3 508856IN4 508856IN5 508856IN6 509473DR5 509473DR6 509473DR7 509946CATH1 512341RI 512447SI 512447SI2 513559INNOVA 513853INNOVA 513861INNOVA 514376CARDIO 514468BINNOVA 514843AINNOVA 516562INNOVA3 516562INNOVA5 516663EP3 516663INNOVA1 518243EP1 518525LAB2 519663INNOVA 520296CATH1 530244XC3 540932INNOVA 541282CV1 541382CV1 541382CV2 541686SPR3 561548CL1 561548CL2 561548CL2 561548EP 561798CATH1 561798CL1 562491INNOVA 563244CATHLAB1 563244CATHLAB2 563421CATHLAB1 563421CATHLAB2 563421CATHLAB4 563421CATHLAB7 570969CATH 573472CATH 573632CRC1 573686CL1 573761SMC1 601268INNOVA1 601553CL1 601553CL2…
Recall started: July 25, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Device Design
What the company told customers: Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.
Recall number: Z-2435-2008

Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner…

Product: Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
Quantity: 229
Codes and lots: 201447LAB1 202782LABC 2035762100 208227CATH1 208367INNOVA 208381CCL1 212305CATH1 212604INNOVA1 214947MINNOVA 214947MINNOVA2 215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3 251435ICV7 252384CATH1 253627INNOVA1 262255INNOVA2 262255INNOVA2 262687CL2 303369HCL4 303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1 310825INNOVA21 317355INNOVA3 318448INNOVA3 330363LAB3 330375LAB2 336538ARCL 336832MCCL6 360456XCL4 402559UCC 402559UCD 405604D2100 408559INV1 409938INV21 410337INNOVA6 410554INNOVA1 410554INNOVA2 410554INNOVA3 410554INNOVA4 4107872100 412367LAB2 414291CL2 414649INNOVA2 416480INNOVA 416864INNOVA 416864INNOVA2 417269SCLA 417347FCV2 417347FCV4 423495MCATH1 4436432100 501257VALAB1 505848CATH1 505848EP 508335INNOVA 508856IN21 508941IN21 509575YM2100 516562INNOVA2A 516562INNOVA6 516562INNOVA7 516632INNOVA1 518243LAB1 518243LAB2 541732CV2 541743CL3 561548ET2 570476INNOVA21 573256MHC 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 604682INNOVA1 604682INNOVA2 604875AINNOVA1 604875AINNOVA2 607737CL1 608775NOVA1 608775NOVA2 610250INNOVA1 610250INNOVA3 610776INNOVA21 610983INNOVA2 612273INNOVA2 615284CV3 615342CV3 615446CV1 615515OPCL 617636CL1 619457INNOVA6 619552INNOVA2 630856H2100 650369SV4 65049321 651582IN3 661327INNOVA1 661327INNOVA2 7023602100 704384CL21 706291CLIN1 713375U2100 713794LAB1 717217INN21 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727521CATH2 727521CATHOP 727869CATH3 727869CCL2 727869EP5 727942CATH2 732324INN1 732776CATH4 732923INN 770HMCCL1 775982INN2100 781340IN1 781340IN3 785354HRTEP 803256PCL5 804764CATH2 8053702100 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 8157412100 815759CARDIAC1 816861KCVAI2 817329BG2100 8184092100 828213IN21 843692CATH3 843724CL1 843724CL2 843724CL3 843724EP1 843797EP 843797TCL1 845365V13 845368LAB1 845368LAB2 847316INNOVA1 847316INNOVA2 856853IN2100 857307IN421 858554INNOVA2 858554INNOVA3 864255SFCL1 864255SFCL2 865693CCL 865693CCL2 865977CCL 901765EP 904597CATH 905848INNOVA1 910343EP1 910343EP2 910671INOV21 916781INNOVA2 9284532100 937208INNOVA2 949250I21 954735CL2 954987CCL7 954987CCL8 954987CL4 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP LVINOV7 PRESBYDEP RPINNOVA2100 2637041 2680771 2683172 2686112 2706718 2710562 2713664 2713687 2715023 2718602 2729712 2730402 2730405 2730406 2731313 2731570 2731573 2731583 2738012 2741780 2749861 2754702 2755150 2756171 262687CL1 316689MP 541677MINNOVA2 541789CV1 609267IN2100 609757IN2100 610645LAB10 760940INNOVA2, and 828315FIN2
Recall started: July 25, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Device Design
What the company told customers: Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.
Recall number: Z-2436-2008

Innova 3100 / 3100 IQ…

Product: Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
Quantity: 375
Codes and lots: 2652143 2014183100 201541LAB2 201996LAB1 2035763100 2035763100A 2036883100 205783BCL5 205877CCL1 205877CCL2 207351YCL1 207662CL4 207879CL131 208227CATH2 209334LINNOVA1 214324INNOVA2 214590PH3100 215335INNOVA1 215576INNOVA1 219326IN31 2197573100 219877IN2 219877IN31 228818VASC 239436CATH3 239513CRLAB1 239939CLA 251435ICV6 251633PROV 253968INNOVA 254742KDCL1 262687CL3 270688INN 281420LAB1 281420LAB23100 281440CL3 3027443100 303425CL4 303629CL4 303629EP 303788CL2 305364P3100 308865GIN2 309691P3100 310319SM3100 310423INNOVA1 310825INNOVA31 312STMNAZ3100 313593IC1 313593IC2 314525STACL2 314768SMCL1A 314768SMCL3 316268INNOVAA 316651INNOVA31 316962WCVC1 316962WCVC2 318448INNOVA2 318449INNOVA2 318798CL1 325428CATH1 325428CATH3 334418CL 336832MCPV 337374INNOVA 352333CATH1 352333CATH2 360456XCL3 361857CATH1 361980INNOVA2 402559UCB 404686CRI3 405272SCL2 405372S3100 405604D3100 405610NW3100 405840OIC3100 406447VAIN3 406543IN3 409899LAB3 4103323100 4103623100 412437INNOVA 413447CATH 413540IN1 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417269SCLD 417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 479441SP3100 480728LAB2 480821IN2 502587LAB1 502587LAB4 502852INNOVA 5033703100 5034353100 507385INN3100 508856IN2 508941IN1 509946CATH2 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516632INNOVA2 516663INNOVA1A 516663INNOVA2 518525LAB1 530244XC106 540953INNOVA 541382CV3 541677MINNOVA1 541743CL6 541MWHINNOVA 561266IN31 561548CL4 570476INNOVA31 573458CL1 573632CRC2 573815BCR1 573882UMC1 580548B3100 6012883100CV2 601553CL3 601883CL1 602239LAB4 602239LAB6 602266LAB2 603421PCL 603580ECL1 608524NOVA 609757IN3100 610447CL1 610526LAB1 610526LAB2 610595CL1 6106483100 610770INNOVA31 610891CL1 610954INNOVA1 610983INNOVA1 615338CV2 615769SKYCV2 616392INNOVA 617732IN9 617789IN1 618241GSI3100 619340VA8 619457INNOVA5 619482INNOVA1 619541INNOVA31 619552INNOVA1 620225INNOVA31 630312B31 630856H31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 65049331 6619483100 662377CV2 662377CV4 671GMHAINVA 678957INNOVA 7018573100 7022333100 702616INNOVA 7028533100 7028803100A 704355RM2 704384CATH2 704384PHMCATH 704878CL31 706481CCL 706774CCL4 706774CCL5 7083333100 708WESTSUB3100 713359INC 713776M3100 713794LAB7 713794LAB9 713948INA 714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31A 717782INNOVA31B 718245UNITY 718250CATH1 718270INNOVA1 718283INNOVA3 718470INNOVA2 718780CATH2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV 732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1 770991CL3 772LWCL1 773792CL3100 773NORWG3100 775982CATH2 781340IN2 785354S3100 8014793100 8019643100 803255CL1 803256PCL1 803329CL31 804285CATH1 8053703100 808547QCV2A 812238LIB1 812283IN31 812450CATH1 812450EP1 812450EP1 812482INNOVA 812858GWLAB1 812858GWLAB2 814676C1 815226INN2 815344CARDIAC3 815599FHN3100 8157413100 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816969LSCATH 816985NKCI 817433HSW3100 8184093100 8185023100…
Recall started: July 25, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Device Design
What the company told customers: Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.
Recall number: Z-2437-2008

Innova 4100 / 4100 IQ…

Product: Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
Quantity: 378
Codes and lots: 201541SP1 2035764100 204787INNOVA1 205759CL2 209467INNOVA308 216844INNOVA 219326IN41 2194654100 229228INNOV41C 229228INNOV41V 22925941V 22925941V2 229434INNOV 239436CATH1 239939INNOVA 248849SP1 250370INNOVA 251435I12 251435ICV5 252816INNOVA 252847PRS2 252847PRS3 269226IN1 269226IN2 269226IN2 269983IN41 281401T4100 3016094100 3018774100 3027444100 303320OR41 303399IR 303436ANGIO 303839CL1 304255INNOVA 304255INNOVA 304256INNOVA 304347INNOVA 304347INNOVA2 304424CCINOVA 305823IN4100 305835IN41 306766INNOVA 308534ANG 309343CSP1A 309655FSP1A 309655FSP3A 309672M4100 312792R4100 313343SP1 313876SP41 314569SJRM12 314966DPHSP 315448RM4 315448RM5 316651INNOVA41 316962INNOVA41 317338PV3 317887INNOVAPV 3184734100 319338VA4100 325670CATH 330489SPEC9 334286BSP 337981INNOVA 352333INVOR 352333VASC 352376SP 352401CATH 352401VASC 352596SPEC 360754INNOVA 386254HS1 386254HS2 386HPOS1 401274IN41 404466SF41A 404616INNOVA 404GHSIR1 404GHSIR2 407518SP2 407518SP3 407SPECIALS 4082594100 409212INOV41 4103374100 410337INNOVA2 4105434100 412623LAB1 412623LAB3 412647OR10 412784LAB1 412784LAB2 4134474100 4135344100 4137484100 414328INN4100 414649CL2 414649DVI 414961INN4100 4163694100 416756INNOVA 419251LAB1 419557ORLAB 419696LAB1 423493I4100 423495ENDO2 423495M4100E 423495MSPEC2 4438494100 478633INOV 478765ANG1 480512SP 5033704100 505848CATH2 505848V4100 508383IN4100 508650IN41 508856OR41 5094744100 509474SH41 509482HFI 509575YM4100 512528CPCL1 512901NI4100 5134754100 5135844100 5136864100 5136864100 5138534100 514376INNOVA 514842AINNOVA 514934BANGIO 515263IL4100 516562INNOVA4 519663INNOVA2 519685INNOVA 530888ANG206 541282CV2 541686SPR1 5417684100 561548VAS2 561694IN1 561747IN4 561776IN41 561784INSP 5703214100 570321LAB2 5705224100 573632CRA 573761SMA 574294IN41 574535IN41 574647IN2 574647IN41 574647IN41 586573SP1 6012884100SP1 601376SP4100 6029234100 603650ANG1 604557INNOVA 605333RM10 606833INNOVA 6082634100 608263ACT 608263XMR 608324DAL 609652CATH3 609652CATH3 610954INNOVA41 610954INNOVA41 610988INNOVA4 613548INNOVA3 614293LIBERTY1 614293LIBERTY2 615284OR15 617525IN1 617636IN1 617726RF2Y6 618549CM4100 619229INNOVA1 620665INNOVA41 623848SP 626359INNOVA 630275G41 630275G41B 6309784100 650369SV5 650493ANGIOCT 6616324100 662244GTSP 678EJCIR1 7023604100 7028804100 704487CR41 706278INNOVA1 706291RINN 706291RINN2 706651SP1 706733SP1 706774USP3 706802FINN 708202VA41 7087564100 708783CL4100 708783SP4100 708WESTSUB4100 713375U4100 7137764100 715369INN4100 717763INNOVA41 717763OR4100 718206LIBERTY1 718250ANGIO 718518CVL1 718630LIBERTY 719560INN41 724656ANG 727398SPEC1 727725SPEC1 727791INNOVA 727819SPSC 740592INNOVA 757398INNOVA 757736INNOVA 757736INNOVA 757889INNOVA 757889INNOVA 760633IR1 770535N4100 770736SP1 773878SWGANGIO1 77573841 801268INNOVA 80140841 8014794100 80158241 80180741 802295VALCA 803256SP 803329CL41 804285CATH2 804320CATH2B 804594ANGIO 804594CATH 804764CATH3 810342A41 812238UN41 812279INNOVA1 812825INNOVA1 812858GWSP 813558INTV 813615CL10 813745INTV 813972INTV…
Recall started: July 25, 2008
Device type: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Root cause (FDA): Device Design
What the company told customers: Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.
Recall number: Z-2438-2008

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

Source: FDA · Medical device enforcement reports, recall numbers Z-2435-2008, Z-2436-2008, Z-2437-2008, Z-2438-2008. The agency record governs; check it and the company before acting.

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