Class 2 Device Recall Digital Fluoroscopic Imaging System

• Date Initiated by Firm: June 17, 2008
• Date Posted: June 19, 2009
• Recall Status: Terminated on October 22, 2014
• Recall Number: Z-1476-2009
• Recall Event ID: 49524
• 510(K)Number: K023178 K042053 K052157 K052412 K061163
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• Product: GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
• Code Information: System ID Number: 304347INNOVA2, 574647IN2, 317621PVAW 317621PV , 248849SP1, 412784LAB1, 412784LAB2, 7087564100, 478765ANG1, 209467INNOVA308, 620665INNOVA41, 409212INOV41, 727398SPEC1, RADNETXV2, MCL4100, 601376SP4100, 718250ANGIO, 615284OR15, 618549CM4100, 419557ORLAB, 3184734100, 706774USP3, 6309784100, 6616324100, 304256INNOVA, 2035764100, 352596SPEC, 423495MSPEC2, 5135844100, 719560INN41, 303320OR41, 303399IR, 303436ANGIO, 3027444100, 574294IN41, 239939INNOVA, 252847PRS3, 864255SF4100, 305823IN4100, 7137764100, 3016094100, 414649CL2, 812858GWSP, 212639ACT1, 8014794100, 304424CCINOVA, 309655FSP1A, 4134474100, 5033704100, 509474SH41, 201541SP1, 281401T4100, 918744JR4100, 22925941V2, 586573SP1, 314569SJRM12, 314966DPHSP, 317887INNOVAPV, 330489SPEC9, 352333INVOR, 386254HS1, 386254HS2, 386HPOS1, 404466SF41A, 404GHSIR1, 410337INNOVA2, 412647OR10, 414649DVI, 419696LAB1, 505848CATH2, 505848V4100, 508650IN41, 509482HFI, 512901NI4100, 530888ANG206, 541686SPR1, 561548VAS2, 570321LAB2, 605333RM10, 610988INNOVA4, 617636IN1, 619229INNOVA1, 623848SP, 630275G41, 630275G41B, 650493ANGIOCT, 662244GTSP, 678EJCIR1, 706291RINN2, 706651SP1, 706733SP1, 708783CL4100, 708783SP4100, 713375U4100, 718630LIBERTY, 727791INNOVA, 770535N4100, 803256SP, 804594ANGIO, 812238UN41, 812825INNOVA1, 813615CL10, 815740SC4100, 817465AR4100, 817922BA4100, 843577CL2, 845368RM10, 850747IN4100, 863687INV24, 864573LAB2, 865373SP, 865481SUR, 908522SP1, 915577SP1, 918682IN41, 954MW4100, 970247INNOVA, COR359867, DR4100, FHORL4100, PEMBROKE4100, RADNETXV1, RHD4100, 480512SP, 8458584100, 770736SP1, 423495M4100E, 423493I4100, 8593134100, 313343SP1, 708202VA41, 708WESTSUB4100, 509575YM4100, 80140841, 80180741, 2194654100, 4082594100, 4105434100, 4137484100, 5094744100, 5417684100, 5703214100, 5705224100, 6082634100, 7023604100, 7028804100, 219326IN41, 229228INNOV41C, 22925941V, 251435I12, 252816INNOVA, 269226IN1, 269226IN2, 269983IN41, 303839CL1, 308534ANG, 309672M4100, 312792R4100, 313876SP41, 316651INNOVA41, 317338PV3, 360754INNOVA, 401274IN41, 412623LAB1, 412623LAB3, 414328INN4100, 419251LAB1, 508383IN4100, 512528CPCL1, 541282CV2, 603650ANG1, 608263ACT, 608263XMR, 608324DAL, 610954INNOVA41, 617525IN1XX (617525IN1), 617726RF2Y6, 626359INNOVA, 650369SV5, 706291RINN, 718206LIBERTY1, 760633IR1, 773878SWGANGIO1, 801268INNOVA, 804285CATH2, 804764CATH3, 810342A41, 813558INTV, 816943SP1, 817433HSW4100, 828298VASC, 847842GS4100, 856365ANGIO, 903GS4100, 904202SP1, 904BSSP, 913317SLS4100, 952993INNOVA2, 972335LIB, 972487ANGIO1, 972566INNOVA3, 985867INNOVA2, ECXV1406E, MIRAMAR41, WCATHLAB41, 334286BSP, 757889INNOVA, 706278INNOVA1, 561747IN4, 252847PRS2, 918744JC4100, 5136864100, 850494WSP1, FWANG3217, 309343CSP1A, 309655FSP3A , 802295VALCA , 574647IN41, 480512SPUPS (480512SP), 843674VAS1, 630275AW41 (630275G41B), 0002651236AX (813745INTV), 414328INNAW (414328INN4100), 317621PV, 630275AW41B (630275G41B), 316962INNOVA41, 906485ANGIO, 4135344100, 85931341002, 423495ENDO2, 847316INNOVA41, 215537INNOVA1, 561784INSP, 4436434100, 843797TIR2, 305835IN41, 303839CL1, 318681INNOVA1, 853060196, 853060187, 06004VAS02, SK1110VA02, E001RX08, SA1005VA06, RU2278VA01, 600152VA01, RU2714VA01, RU2992VA01, RU1050VA03, RU1106VA02, RU1326VA01, 787620IN4100, 787653INNOVA, 600042VA02, NO1037VA01, NO1015VA04, BRD0411, MA1251VA01, MA1020VA01, LT4001VA02, LB1037VA01, KW1001VA03, KW1001VA04, KW1018VA04, KW1013VA01, 850060718, 850060720, 850060721, 850060722, 850060725, 850060707, YV0012, XF0150, XF0151, XF0152, XF0153, XF0154, XF0155, XF0200, YV0006, YV0007, XF0156, YV0009, XF0022, XF0149, YV0001, YV0002, YV0004, YV0010, XF0157, YV0012, B5129910, A5102671, A5163317, A5605732, A5105151, C5603903, 8.30062E+13, IL1043VA01, IE1100VA01, HU1039VA02, 00490VAS02, 01278VAS01, 10091VAS01, 00137VAS01, 00171VAS01, 00860VAS01, 00065VAS01, M2030711, M1230007, N4192927, R4211476, M4505274 , FI1015VA01, DE641223, DE188442, HC0220XR07, 407953XR01, 487692XR01, UC1129XR33, 600002VA01, CS1054VA01, 514842AINNOVA, 613548INNOVA3, 4163694100, 250370INNOVA, 306766INNOVA, 416756INNOVA, 514376INNOVA, 514934BANGIO, 519663INNOVA2, 519685INNOVA, 204787INNOVA1, 604557INNOVA, 82406070010, 82406310005, 82416030007, 82416040020, 82416100016, 82416130020, 82416130021, 82416130025, 82416220006, 82406040022, 82406120016, 82416130010, 82416130011, 82416130013, 82416140005, 82416160005, 82416160010 and 190020RX09; and Serial Numbers: 00000008C20030, 00000008C20052, 00000008C20051, 00000556127BU9, 00000007C20218, 00000007C20337, 00000007C20148, 00000007C20308, 00000007C20312, 00000007C20249, 00000007C20320, 00000007C20362, 00000008C20038, 00000007C20330, 00000008C20001, 00000007C20316, 00000008C20020, 00000007C20341, 00000008C20034, 00000464131BU2, 00000524362BU1, 00000513090BU1, 00000477792BU6, 00000520079BU5, 00000464074BU4, 00000471490BU3, 00000007C20020, 00000453906BU0, 00000453926BU8, 00000464072BU8, 00000536790BU9, 00000519096BU2, 00000513264BU2, 00000500002BU1, 00000498705BU3, 00000509203BU6, 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00000067077VE8, 00000526544BU2, 00000526673BU9, 00000067056VE2, 00000513101BU6, 00000444298BU4, 00000007C20028, 00000479498BU8, 00000498074BU4, 00000441209BU4, 00000526354BU6, 00000513520BU7, 00000403984BU8, 00000526300BU9, 00000512684BU2, 00000435074BU0, 00000479553BU0, 00000498091BU8, 00000008C20155, 00000444268BU7, 00000093715VE1, 00000444264BU6, 00000479552BU2, 00000526535BU0, 00000067053VE9, 00004411628BU2, 00000512835BU0, 00000526652BU3, 00000444252BU1, 00000479551BU4, 00000093721VE9, 00000526651BU5, 00000526552BU5, 00000526676BU2, 00000007C20204, 00000444277BU8, 00000526530BU1, 00000411063BU1, 00000530105BU6, 00000512746BU9, 0000000000LIB7, 00000498257BU5, 00000432299BU6, 00000444239BU8, 00000055093VE9, 00000434364BU6, 00000067064VE6, 00000077916VE5, 000786324-0006, 00000416900BU9, 00000077914VE0, 00000403215BU7, 00000007C20345, 00000007C20239, 00000007C20127, 00000441207BU8, 00000007C20103, 00000007C20139, 00000477811BU4, 00004986775BU8, 00000513125BU5, 00000008C20051, 00000477811BU4, 00000008C20049, 00000007C20301, 00000007C20370, 00000008C20016, 00000008C20019, 00000008C20043, 00000008C20053, 00000008C20063, 00000008C20066, 00000008C20067, 00000008C20069, 00000498150BU2, 00000008C20064, 00000007C20160, 00000093730VE0, 00000513250BU1, 00000008C20028, 00000479536BU5, 00000489745BU0, 00000007C20357, 00000477771BU0, 00000519098BU8, 00000453917BU7, 00000520060BU5, 00000512708BU9, 00000007C20280, 00000510196BU9, 00000441173BU2, 00000464083BU5, 00000008C20050, 00000526536BU8, 00000444262BU0, 00000007C20367, 00000479532BU4, 00000536806BU3, 00000498660BU0, 00000512721BU2, 00000007C20046, 00000489727BU8, 00000067072VE9, 00000453940BU9, 00000479528BU2, 00000477754BU6, 00000489682BU5, 00000477806BU4, 00000479485BU5, 00000008C20023, 00000485917BU9, 00000477742BU1, 00000513522BU3, 00000513142BU0, 00000489693BU2, 00000498694BU9, 00000489734BU4, 00000486219BU9, 00000477773BU6, 00000007C20153, 00000007C20188, 00000539161BU0, 00000441206BU0, 00000416899BU3, 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• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: GE Healthcare has become aware that a few customers have experienced an unusual occurrence of system lockups on Innova single plane cardiovascular X-ray imaging systems while using the image auto-archiving function. when occurring during X-Ray imaging, the acquisition fails and the user has to rest the system. To date, one patient death has been reported related to this issue.
• FDA Determined Cause: Process control
• Action: GE Healthcare sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Health Care Professionals describing the problem with the affected devices including instructions to avoid further problems until a GE Healthcare service representative is able to make contact and upgrade the system. Further questions may be addressed by calling 1-800-437-1171.
• Quantity in Commerce: 356 plus 11 either 3100 or 4100
• Distribution: Worldwide Distribution - US including Puerto Rico and states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY,NC, ND, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,WV and WI and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GEORGIA, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SPAIN, SUDAN, SOUTH AFRICA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, VENEZUELA and SOUTH AFRICA.
• 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; 510(K)s with Product Code = MQB; 510(K)s with Product Code = MQB