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-0620-2010
  • 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=86543
  • 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
    201996LAB2 201996LAB3 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 251435ICV4 252443NGIN1 253627INNOVA2 253627INNOVA3 254519I2K 256341IN1 256386IN1 256880IN1 262243INNOVA1 262255INNOVA1 262569INNOVA 281338INA 281351TINNOVA 281440LAB2 281440LAB3 281540NECATH 281893INNOVA 301891CATH1 303320CL1 303320CL2 303369CL2 303425HCL1 303673CL1 303715CL1 303730CL1 303778CL1 303778CL2 305223IN1 305223IN2 305325CCL3 305325CL4 305585CL2 305585CL3 308865PHI 309454BINNOVA 309691HCL1 309691PINNOVA 310423INNOVA3 310423INNOVA4 310423INNOVA5 310423INNOVA7 312792RINOV2 313343LC 314569JC1 314966DCL2A 314966MHC 315448RM1 315448RM2 315448RM3 316268INNOVAEP 316689INNOVA1 317621EP2 317621INNOVA1 317621INNOVA2 317621INNOVA3 317818I2K190 317818I2K905 317818MDI915 317887INNOVA1 317887INNOVA2 318448INNOVA 318449INNOVA1 321HCL4 321HCL5 321PBCL1 330375LAB1 330837INNOVA 336716BCL1 336832MCCL1 336832MCCL3 337289INNOVA 352344CATH1 352INVCATH 361788NOVA 401274IN3 402280CIN1 402280CIN2 404265AMC2 404305SF1 404686CRI1 404686CRI2 404712EI1 405272SCL4 407321INCL1 407518CL1 407518OPCL 408259INV 410337INNOVA1 410337INNOVA3 410337INNOVA4 410337INNOVA5 410543CATH1 410543CATH6 410614CV7 412232B 412367LAB1 412367LAB3 412623LABB 412623LABI 412647LABA 412647LABB 412647LABC 412647LABD 412784C1 413748INNOVA 414219INNOVA 414291CL3 414649INNOVA 414805INNOVA2 414961INNOVA 415206CATH 415750SCL1 415750SCL2 417269SCLB 417269SCLC 417885JCL1 417885JCL2 417885JCL3 417885JCL4 419227CL3 419526INNOVA3 419526INNOVA4 423493PCL3 423495CHIRM1 423559BCL1 423844CCL2 440835INNOVA 443481INOVA1 478765CTH2 480512IN1 480512IN3 480728LAB1 480821IN1 501484LC3 501686UAINNOVA 502587L2 502587LAB3 502587LAB5 503215INNOVA 504391INNOVA 504447INNOVA 505983CATH 508798INC2 508856IN3 508856IN4 508856IN5 508856IN6 509473DR5 509473DR6 509473DR7 509473ICINOV 509946CATH1 512341RI 512447SI 512447SI2 513559INNOVA 513853INNOVA 513861INNOVA 516562INNOVA5 516663EP3 516663INNOVA1 518243EP1 518525LAB2 520296CATH1 530244XC3 540932INNOVA 541282CV1 541382CV2 561548CL1 561548CL2 561548EP 561798CATH1 561798CL1 562491INNOVA 563244CATHLAB1 563244CATHLAB2 563421CATHLAB1 563421CATHLAB2 563421CATHLAB4 563421CATHLAB7 570969CATH 573472CATH 573632CRC1 573686CL1 573761SMC1 601268INNOVA1 601553CL1 601968INNOVA 602239LAB1 602588INNOVA 603228CCL2 603433PLC1 603650CATH3 603668CLCB 605719INNOVA1 605719INNOVA2 606439INNOVA 608324CATH 609653INNOVA 609757IN2000 610270INNOVA 610431CL1 610431CL2 610447CL2 610645CL5 610648INNOVA 610954INNOVA 610954INNOVA2 610988INNOVA1 610988INNOVA2 612273INNOVA1 612467INNOVA1 614293INNOVA1 614293INNOVA2 614293INNOVA3 615222STCL3 615222STCL5 615284CV2 615316INOV2 615327CV1 615327CV2 615768CV1 617636CL1 617754IN1 617754IN2 617754IN3 617754IN4 618241GSI 619260INNOVA 619340VA7 619457INNOVA3 619691INNOVA 619739INNOVA 623848LAB1 626915INNOVA 631376INNOVA 631968EP 636916SPCL1 636947JCL3 650696INV1 650723SC6 651582INN1 661949INNOVA 701857I2K 702388INNOVA1 702564INNOVA 702731INNOVA 702731INNOVA2 702731INNOVA3 704487CMIN1 706291RCL2 706651CCL 706721CCL 706774CCL2 706774UC6 707546INNOVA 708202VA2K 708333INOVA 708352L2K 708425INNOVA1 713359INA 713359INB 713776MINNOVA 713794LAB10 713794LAB3 713794LAB4 713897CIN 714229INNOVA 714533INNOVA 714953INNOVA 714999INNOVA 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 760633INNOVA 760940INNOVA1 770228GC1 770991INNOVA 773702INNOVA 773878SWGCATH1 773878SWGCATH2 773878WCL 773884HC2000 773STJINNOVA200 775770CATH1 775982CATH3 785354HRT1 785354HRT2 801299INNOVA 801373CATH1 801373CATH2 801373EP 801479INNOVA 803256CL6 803256PCL3 803256PEP1 803256PEP3 803329CL20 803641CCL 804285CATH4 804320CATH1A 804320CATH3A 804320CATH5 804320CATH6 804764INNOVA 805497INNOVA2 806354INNOVA1 806354INNOVA2 808242INNOVA 812265L1 812283IN20 812376CL1 812450CATH2 813615CL2 814534C1 814765CATH 815226INN1 816932HRT2 816932SLHEART8 816985NKCI2 817255NH2000 817329BGINNOVA 817347MPINNOVA 817465ARINNOVA 817877INNOVA 817922INNOVA 818502INNOVA1 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 864455GMIN1 864455GMIN2 864512EP1 864512EP2 865218CCL1 865481CCL1 865541CCL1 865541CCL2 865541CCL4 865693CCL5 870508LAB3 901384CV3 901726R2 901757CV2 901765CV1 903315INN 903798WINN 904202CATH1 904202CATH2 909865INNOVA1 909865INNOVA2 909CH2000 910343NHIN2 913317SLSHEART1 913791OINCATH 918307SHIN1 918307SHIN2 918341CI 918494IN2A 918744JI1 918744JI2 918744JI3 919934JCL 920288CATH1 920288CATH2 920729INNOVA 920738INNOVA 920926CATH1 928639IN1 936266CL2 936539CL2 937208INNOVA1 940384INNOVA2 940764INOV1 940764INOV2 940764INOV3 940898INN 941483INNOVA1 941483INNOVA2 952993INNOVA 952993INNOVA3 952993INNOVA4 956389INNOVA 956632INOVA 970350CL3 972335INN 972394INNOVA 972540INN 972969INNOVA 973365CATH 973365LAB1 973971EP2 973971LAB1 973971LAB2 973971LAB4 973971LAB5 973972LAB1 973972LAB2 973972LAB3 985867INNOVA1 985882INNOVA CSI214 DR2000 DUCK ECXV1406C EG1112VA01 FHORLCL2 FHORLCL5 FHORLCL6 FHVIN2000 FLGRCATH1 FLGRCATH2 FWCL3772 KMCINNOVA LIJ016133 LVEPINOV5 LVINOV1 LVINOV2 LVINOV3 MCTHSC1 MCTHSC2 MCTHWHS1 MOUSE WCATHLAB2000 310540INNOVA 0853060171 0853060179 07010VAS01 16016VAS01 61006VAS02 TN1012VA01 TN1059VA01 TN1166VA01 TN1193VA01 TN1194VA01 0856160001 0856160003 0856160004 0856160005 0856160006 M007RX05 SA1005VA05 SA1054VA01 SA1231VA01 SA1305VA01 600107VA01 RU1016VA01 RU1070VA01 RU1112VA01 RU1463VA01 RU1717VA01 RU2096VA01 RU2167VA01 809840INNOVA 600043VA02 600062VA01 600115VA01 PL1008VA01 PL1101VA02 PL1494VA01 PK1251VA01 0920169001 NO1009VA02 NO1015VA03 NO1064VA01 BRD0409 LDN0210 LWD0302 537527INNOVA 54787LC 83INNOVA2588441 869910INNOVA MQ1000VA01 LT4001RX01 LB1050VA02 0850060674 0850060685 0850060693 0850060708 0850060709 0850060710 0850060712 0850060713 0850060714 0850060717 YX1341 YX1344 YX1346 YX1347 YX1348 YX1349 YX1350 YX1467 YX1468 YX1470 YX1472 YX1473 YX1475 YX1476 YX1477 YX1478 YX1479 YX1481 YX1482 YX1484 YX1485 YX1486 YX1487 YX1488 YX1491 YX1492 YX1493 YX1500 YXX494 YXZ471 JO1034VA01 JO1034VA02 A5101425 A5108235 A5108714 A51088116 A5113511 A51152101 A5119428 A5129951 A5129953 A5129954 A5130609 A5140730 A5154405 A5189713 A5196328 A5203209 A5221706 A5306808 A5359404 A5381110 A5618321 A5618322 A5714604 A5730901 A5807006 B5120716 B5346303 C5343110 C5803117 GOLD001884 IR1501RX01 IR1632VA03 IR1667VA01 082416010002 082416040004 082416040008 082416220005 083016002100785 083016002101753 083016007351458 08301603046202 083016065231713 083016202101303 08301621006236 083016242100883 083016242101073 083016242101355 08301628448937 083016590020020 083016590670229 083016592416686 083016598280220 083016602200116 083016602200254 083016602200304 083016802100484 083016802100854 083016802101285 083016822000444 083016822100515 083016822100563 083016842101033 083016842101276 083049002100406 0850060688 0850060711 0850060715 GS21100002 IL1098XR02 IE1006VA01 IE1018VA02 IE1029VA01 IE1031VA03 IE1031VA04 0835160013 0835160015 0835160016 0835160019 HU1044VA01 0828060057 0828160010 H2009VAS17 H2015VAS15 00023VAS01 00105VAS01 00132VAS01 00133VAS02 00140VAS01 00150VAS01 00171VAS02 00174VAS01 00199VAS03 00199VAS04 00199VAS05 00285VAS01 00285VAS02 00285VAS03 00327VAS01 00391VAS01 00424VAS01 00463VAS05 00490VAS01 00506VAS01 00529VAS01 00577VAS03 00577VAS04 00584VAS03 00584VAS04 00638VAS01 01224VAS02 01224VAS03 01245VAS01 01254VAS01 05217VAS01 10010VAS01 10044VAS01 10086VAS03 10086VAS05 10100VAS04 10100VAS05 10501VAS01 A4194812 A4213138 A9793302 B4498640 B4498642 C2195251 E4167627 FEB52057 M1327506 M1754003 M2002611 M2030707 M2052042 M2208714 M2844529 M4046541 M4159626 M4163751 M86323601 MA1255VA01 PL1107VA03 R4211485 S4160056 X100378801 X76305701 FI1023VA02 FI1126VA01 FI1128VA01 DE203229 FE416040 FE421134 FEE08424 FEE12418 ME256638 MP473910 UE535A69 UP389019 EG1003VA01 2620943IN2000 DZ1027VA01 126430XR03 HBKR01XR04 HC1536XR02 HC1627XR20 HC3121XR01 HC5533XR08 HC5546XR08 HC5546XR09 MC2848XR02 PC2720XR02 PC8109XR02 UC3287XR05 2575962INNOVA 266150XR14 416284INNOVA 416469INNOVA 418656CNOVA1 418656CNOVA2 514376CARDIO 514468BINNOVA 514843AINNOVA 519663INNOVA 613548INNOVA2 615495MCL5 819563CINNOVA1 819563CINNOVA2 905895INNOVA1 905895INNOVA2 905895INNOVA3 082406140017 082406140020 082416010003 082416010004 082416020001 082416020002 082416030001 082416030002 082416040002 082416040003 082416040005 082416040007 082416040013 082416050001 082416070001 082416070002 082416100001 082416100004 082416100005 082416120001 082416120002 082416120003 082416120004 082416130004 082416130005 082416130006 082416130007 082416130008 082416130009 082416140001 082416160004 082416200006 082416210001 082416210002 082416210005 082416220002 082416220004 082416250001 082416250003 082416270001 082416310004 082416310005 BY4015VA01 BY4026VA01 1157760 BR62349 BG4029VA01 BG4029VA03 010120RX39 030232RX07 0910064006 0910162003 0910163001 0910163002 0910163003 0910163004 0910163008 0910163010 0910165002 ZA2162RX01 3882591464VAMET 388558268VASAND
  • 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 2000 fluoroscopic x-ray 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