Events

Recall of Device Recall Innova

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53788
  • Event Risk Class
    Class 2
  • Event Number
    Z-0618-2010
  • Event Initiated Date
    2009-12-22
  • Event Date Posted
    2010-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86541
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    table for x-ray system - Product Code MQB
  • Reason
    Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems. due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
  • Action
    Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Device

Device Recall Innova
  • Model / Serial
    404712SP8 301295EP 309655FSP4A 410740CV 4144473131 540776LGVAS2 541382BP 561881BP1 617525IN13131 630856H3131 630933INVLAB4 718579INNOVABP 773RES3131BP 814877BP 8184093131 COR373252 COR373295 COR373301 ECXV1402B 0853060202 RO1095VA01 0834160005 LY1086VA01 YV0462 A5632421 0853060200 0835160028 00440VAS04 N4192939 2014183100 201541LAB2 201996LAB1 202782LABB 2036883100 205783BCL5 205877CCL2 207351YCL1 207879CL131 208227CATH2 209334LINNOVA1 214324INNOVA2 215335INNOVA1 215576INNOVA1 2197573100 219877IN31 228818VASC 239513CRLAB1 239939CLA 251435ICV6 253968INNOVA 254742KDCL1 262687CL3 281420LAB1 281420LAB23100 281440CL3 2815993100 303425CL4 303629EP 305364P3100 309691P3100 310319SM3100 310423INNOVA1 312STMNAZ3100 313593IC1 314525STACL2 314768SMCL1A 314768SMCL3 316268INNOVAA 316651INNOVA31 316689INNOVA31 316962WCVC1 316962WCVC2 318254CL 334418CL 352333CATH2 352401CATH2 360456XCL3 360SJ3100 361857CATH1 404686CRI3 405272SCL2 405307HCL2 405372S3100 405610NW3100 405636ISW3100 405840OIC3100 409899LAB3 4103323100 4103623100 412232D 412437INNOVA 412623LAB2 413447CATH 413540IN1 414447CL1 414647CL1 414649CL3 414805INNOVA1 417269SCLD 417347FCV5 417885JCL7 417885JCL8 423844CCL1 478274CTH1 479441CV1 479441SP3100 480728LAB2 480821IN2 502587LAB1 502587LAB4 5033703100 5034353100 504447INNOVA2 508856IN2 508941IN1 509946CATH2 512901NI3100 516562INNOVA9 516663INNOVA1A 516663INNOVA2 530244XC106 540953INNOVA 541382CV3 541472CV1 541MWHINNOVA 561266IN31 563421CATHLAB8 570476INNOVA31 573632CRC2 573815BCR1 573882UMC1 575521CATHB 6012883100CV2 601553CL3 602239LAB4 602239LAB6 602266LAB2 606216CATH1 608524NOVA 609267IN3100 609597IN3100 609757IN3100 610447CL1 610526LAB1 610526LAB2 610891CL1 615338CV2 617732IN9 617754IN31 617789IN1 619340VA8 619482INNOVA1 619541INNOVA31 619552INNOVA1 620225INNOVA31 630856H31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 650723SC2 650938LY31 662377CV4 678957INNOVA 7022333100 702616INNOVA 7028803100A 704355PCL 704878CL31 706481CCL 706774HT8 7133933100 713776M3100 713794LAB7 713794LAB9 714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31B 718250CATH1 718270INNOVA1 718283INNOVA3 720225CL2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV 732776CATH2 732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1 770HMCCL2 773792CL3100 773NORWG3100 775982CATH2 8019643100 803256PCL1 803329CL31 803776CL1 804285CATH1 8053703100 808485INNOVA 812237THR31 812238LIB1 812283IN31 812450CATH1 812450EP1 812482INNOVA 812858GWLAB1 812858GWLAB2 814231C1 814676C1 815226INN2 815226OSFLAB1 815344CARDIAC3 815599FHN3100 815756KCHSPEC 816478MC1 816861KCVAI1 816969LSCATH 816985NKCI 817433HSW3100 8184093100 8189813100XX 843692CATH2 843797TCL2 845365V19 847362CONCATH4 850469BCV1 850678IN3100 850747BR3100 856596IN3100 8613100 864512CL3 865481CCL2 865693CCL1 901516R3 903HC3100 903UT3100 904202CATH3 908522LAB1 909464IN3 909788INNOVA1 909CH3100 910343NHIN4 912486CATH1 918333JPIN1 918494IN31A 919731WMINOV 919784REP1 9202623100 925779INNOVA408 928779INNOVA1 931459CV1 936266CL1 940626DCH3100 941798CLAB2 952993INNOVA5 956389INN31 956698INN31 956994INN1 956994INN2 970350CL1 9734293100 973877LAB4 973971LAB3 979MGINV31 985966INNOVA BPINNOVA1 BPINNOVA2 BPINNOVA3R BPINNOVA5 ECXV1406B FHORLCL1 FHORLCL7 KMC3100 LVINOV4 MCDCATH4 YV0036 UA4230VA01 21007VAS02 44009VAS01 34078VAS01 SA1010VA02 RU1295VA02 RU1354VA01 RU3260VA01 600098VA01 600123VA02 600130VA01 RU1001VA02 RU1013VA02 RU1102VA02 RU1142VA01 RU1156VA01 RU1254VA01 RU1295VA04 RU1475VA01 RU1550VA01 RU1899VA01 RU1913VA02 RU2442VA01 RU2457VA01 RU2558VA01 RU2581VA01 RU2741VA01 RU2747VA01 RU2886VA01 RU2969VA01 RU3092VA01 RU3305VA01 787844INNOVACL4 PL1008VA02 PL1082VA01 PL1491VA01 PL1553VA01 PL1650VA02 PL1681VA01 2048000INNOVA 2664627INNOVA 2685467INNOVA 2716439INNOVA NO1005VA05 0834160003 1257060INNOVA 477XVIN2553211 52XVINN2565367 818INNOVAHM1 818INNOVAHM2 818INNOVAHMS1 83INNOVA1188379 INNOVA2762218 LB1003VA01 LB1160XR07 0850060719 0850060724 0850060726 0850060727 YV0172 YV0022 YV0023 YV0024 YV0025 YV0026 YV0027 YV0028 YV0029 YV0030 YV0034 YV0035 YV0037 YV0043 YV0048 YV0050 YV0166 YV0167 YV0170 YV0171 YV0175 YV0176 JO1000VA01 A5105732 A5108239 A5125119 A5162256 A5203215 A5718004 B5274834 B5332001 IR1747VA01 IR1819VA01 IQ1083VA01 IQ1165VA01 082416040026 082416060004 IL1098VA01 0835160023 HU1099VA04 24516572980IN H1420VAS04 H4672VAS02 GE1004VA01 00203VAS01 01243VAS03 01367VAS02 M2002624 M2148236 M2848425 M2970614 M4016034 M40480151 M4163030 M4198062 M9162723 FI1064VA01 FI1314VA02 DPL32931 FPA99414 FPG30528 FPG93008 MPX82206 2655786INNOVA 2625365INNOVA 2735407INNOVA 082416160018 082416250004 082416010006 082416020005 082416030003 082416030006 082416030008 082416030010 082416040010 082416040015 082416040016 082416040018 082416040022 082416040028 082416060002 082416070004 082416080001 082416100006 082416100008 082416100010 082416100013 082416110002 082416110003 082416110004 082416120005 082416120006 082416120007 082416120010 082416120011 082416120012 082416120017 082416130015 082416130017 082416140002 082416140003 082416150001 082416160003 082416160006 082416160011 082416160012 082416160013 082416160014 082416160017 082416180004 082416190001 082416190002 082416190003 082416210003 082416210004 082416210006 082416210009 082416210012 082416210015 082416220008 082416220009 082416230005 082416270002 082416290002 082416310003 082416310006 BY4067VA02 BY4069VA01 BY4066VA01 BY4072VA01 2573329 2667313 2676587 2703876 2722497 2722671 2728403 140024RX09 0910064009 0910064007 0910064008 0910162006 0910163006 0910163007 0910163009 0910163012 0910163015 2722INV31 4127INV31 AE1005VA01 3882569347VAMET 388262854VASCTR 3882643330VACTR 3882643435RXAND 388567772VASMET TT-2577762-CO TT-2586581-CO
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.
  • Product Description
    Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA