510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-1476-2009

GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. The product is...

GE Healthcare / initiated 2008-06-17 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

GE Medical Systems, LLC began a recall of GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. The product is indicated for use in generating fluoroscopic images... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1476-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
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.
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
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 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