Class 2 Device Recall GE Innova 2000 Fluroscopic xray system

• Date Initiated by Firm: July 25, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-2435-2008
• Recall Event ID: 49105
• 510(K)Number: K993037 K022322 K024200
• Product Classification: Solid State X-Ray Imager - Product Code MQB
• 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.
• Code Information: 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 601968INNOVA 602239LAB1 602588INNOVA 603228CCL2 603433PLC1 603650CATH3 603668CLCB 604682INNOVA 605719INNOVA1 605719INNOVA2 606439INNOVA 608324CATH 609267INNOVA 609267INNOVA 609652CATH2 609653INNOVA 609757IN2000 610270INNOVA 610431CL1 610431CL2 610447CL2 610645CL5 610648INNOVA 610954INNOVA 610954INNOVA2 610988INNOVA1 610988INNOVA2 610988INNOVA3 612273INNOVA1 612467INNOVA1 613548INNOVA2 614293INNOVA1 614293INNOVA2 614293INNOVA2 614293INNOVA3 615222STCL3 615222STCL5 615284CV2 615316INOV2 615327CV1 615327CV2 615495MCL5 615768CV1 617754IN1 617754IN2 617754IN3 617754IN4 618241GSI 619260INNOVA 619340VA7 619457INNOVA3 619691INNOVA 619739INNOVA 623848LAB1 626915INNOVA 631376INNOVA 636916SPCL1 636947JCL3 650696INV1 650723SC6 651582INN1 661949INNOVA 701234GE2 701234GE3 701857I2K 702388INNOVA1 702564INNOVA 702731INNOVA 702731INNOVA2 702731INNOVA3 704487CMIN1 706651CCL 706721CCL 706774CCL2 706774UC6 707546INNOVA 708202VA2K 708333INOVA 708352L2K 708425INNOVA1 708597EP 713359INA 713359INB 713776MINNOVA 713794LAB10 713794LAB3 713794LAB4 713897CIN 713964BIN 714229INNOVA 714533INNOVA 714953INNOVA 714999INNOVA 716859BGEP 717270INNOVA1 717270INNOVA2 717544CATH1 717544CATH4 717763INNOVA 717763INNOVA2 717782INNOVA 718226INNOVA1 718226INNOVA2 718283INNOVA1 718283INNOVA2 718780CATH1 718918CATH1 718963INNOVA1 719560HCL2 719776CL1 719776CL2 720225CL1 724284CL 724773C2 724773C3 727521CATH3 727725CATH1 727825CATH 727869CATH1 732557INNOVA 732776CATH1 732776CATH5 740439CATH 740454INNOVA1 740454INNOVA2 757886CATH1 757886CATH1 760633INNOVA 760940INNOVA1 770228GC1 770991INNOVA 773702INNOVA 773878SWGCATH1 773878SWGCATH2 773878WCL 773884HC2000 773STJINNOVA200 775770CATH1 775982CATH3 785354HRT1 785354HRT2 801299INNOVA 801373CATH1 801373CATH2 801373EP 801429INNOVA 801479INNOVA 803256CL6 803256PCL3 803256PEP1 803256PEP3 803329CL20 803641CCL 804285CATH4 804320CATH1A 804320CATH3A 804320CATH5 804320CATH6 804764INNOVA 805497INNOVA1 805497INNOVA2 806354INNOVA1 806354INNOVA2 808242INNOVA 812265L1 812283IN20 812376CL1 812450CATH2 812450CATH2 813615CL2 814534C1 814765CATH 815226INN1 816932HRT2 816932SLHEART8 816985NKCI2 817255NH2000 817329BGINNOVA 817347MPINNOVA 817465ARINNOVA 817877INNOVA 817922INNOVA 818502INNOVA1 819563CINNOVA1 819563CINNOVA2 828262CL 828298CCL 828322FIN 831462CL1 831624INV1 832355SMIN 843339INNOVA 843577CL1 843674INNOVA 843692INNO 850325INNOVA1 850325INNOVA2 850494INNOVA 850494INNOVA2 850862INNOVA1 850862INNOVA2 856342INNOVA 859233INNOVA1 859233INNOVA2 859276INNOVA 859313CL6 859313CL7 860210CV 860358CV 861EP2 864261CL1 864261CL2 864455GMIN1 864455GMIN2 865218CCL1 865481CCL1 865541CCL1 865541CCL2 865541CCL2 865541CCL4 865693CCL5 870508LAB3 901384CV3 901726R2 901757CV2 901765CV1 903315INN 903798WINN 903870INN 904202CATH1 904202CATH2 905895INNOVA1 905895INNOVA2 905895INNOVA3 908668INNOVA 909865INNOVA1 909865INNOVA2 909CH2000 910343NHIN2 913317SLSHEART1 913791OINCATH 918307SHIN1 918307SHIN2 918341CI 918494IN2A 918744JI1 918744JI2 918744JI3 919934JCL 920288CATH1 920288CATH2 920729INNOVA 920738INNOVA 920926CATH1 928639IN1 936266CL2 936539CL2 937208INNOVA1 937208INNOVA1 940384INNOVA2 940764INOV1 940764INOV2 940764INOV3 940898INN 941483INNOVA1 941483INNOVA2 949753INNOVA 952993INNOVA 952993INNOVA 952993INNOVA 952993INNOVA 952993INNOVA3 952993INNOVA4 956389INNOVA 956632INOVA 970350CL3 970350CL3 972335INN 972394INNOVA 972540INN 972969INNOVA 973365CATH 973365LAB1 973971EP2 973971LAB1 973971LAB2 973971LAB2 973971LAB4 973971LAB4 973971LAB5 973971LAB5 973972LAB1 973972LAB2 973972LAB3 985867INNOVA1 985882INNOVA AL9INNOVAVAN CSI214 DR2000 DUCK ECXV1401A ECXV1406C FHORLCL2 FHORLCL4 FHORLCL5 FHORLCL6 FHVIN2000 FLGRCATH1 FLGRCATH2 FWCL3772 KMCINNOVA LIJ016133 LVEPINOV5 LVINOV1 LVINOV2 LVINOV3 MCTH072 MCTHSC1 MCTHSC2 MOUSE WCATHLAB2000 2548244 2577797 2590608 0002733004A 920020937 0920020937A 0920020937B 202745GEMNET 262548INNOVA 604875INNGEC 631968EP1 843577CL1GP, and ECXV1407I
• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 591
• Distribution: 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.
• 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.