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-0619-2010
  • 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=86542
  • 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
    System ID 2036884100A 6029234100 201541SP1 2035764100 205759CL2 215662INNOVA1 216844INNOVA 219326IN41 2194654100 228809VASC 228VA4100 229228INNOV41C 229228INNOV41V 22925941V 22925941V2 229312IN41OR 229434INNOV 239436CATH1 248849SP1 251435I12 251435ICV5 252816INNOVA 252847PRS2 256429SV1 269226IN1 269226IN2 269983IN41 281401T4100 3018774100 303320OR41 303399IR 303436ANGIO2 303839ANGIO1 303839ANGIO2 303839CL1 304256INNOVA 304347INNOVA 305823IN4100 308534ANG 309343CSP1A 309655FSP1A 309672M4100 312792R4100 313343SP1 313876SP41 314966DPHSP 315448RM4 315448RM5 316962INNOVA41 317887INNOVAPV 3184734100 318681INNOVA1 319338VA4100 325670CATH 330489ORVASC 334286BSP 337981INNOVA 352333INVOR 352333VASC 352376SP 352401CATH 352401VASC 360754INNOVA 386254HS1 401274IN41 404466SF41A 404712SP12 404GHSIR1 404GHSIR2 407518SP2 407518SP3 407SPECIALS 4082594100 409212INOV41 4103374100 410337INNOVA2 4105434100 412623LAB1 412623LAB3 412647OR10 412784LAB1 4134474100 4135344100 4137484100 414328INN4100 414961INN4100 419696LAB1 443481ANGIO1 4436434100 4438434100 4438494100 443849INNOVA 478633INOV 480512SP 5033704100 505848CATH2 505848V4100 508856OR41 5094744100 509474SH41 509482HFI 512528CPCL1 512901NI4100 5135844100 5136864100 5138534100 515263IL4100 516562INNOVA4 516632INNOVA8 541282CV2 541686SPR1 5417684100 561548VAS2 561747IN4 561776IN41 561784INSP 570321LAB2 5705224100 573632CRA 573761SMA 574535IN41 574647IN41 586573SP1 6012884100SP1 6029234100 603650ANG1 605333RM10 606833INNOVA 6082634100 608263ACT 608263XMR 608324DAL 609652CATH3 609757IN4100 610954INNOVA41 614293LIBERTY1 614293LIBERTY2 614722INNOVA1 615284OR15 615342CV7 617636IN1 617726RF2Y6 619229INNOVA1 623207SP 626359INNOVA 630275G41B 650369SV5 650493ANGIOCT 6616324100 662244GTSP 678EJCIR1 7028804100 704487CR41 706278INNOVA1 706291RINN 706651SP1 706724VRA4100 706733SP1 706774USP3 706802FINN 708202VA41 7087564100 708783SP4100 708WESTSUB4100 713375U4100 7137764100 715369INN4100 717763INNOVA41 717763OR4100 717782DVD1 718206LIBERTY1 718250ANGIO 718518CVL1 718630LIBERTY 724656ANG 727725SPEC1 727791INNOVA 757398INNOVA 757736INNOVA 757889INNOVA 773878SWGANGIO1 77573841 801268INNOVA 80140841 80158241 80180741 802295VALCA 803329CL41 804285CATH2 804594ANGIO 804594CATH 804764CATH3 810342A41 812238UN41 812279INNOVA1 813558INTV 813615CL10 815740SC4100 8159374100 816276SP1 816943SP1 817255NH4100 817433HSW4100 828298VASC 828696IN41 843577CL2 843674VAS1 843674VAS2 843789SP1 845368RM10 8458584100 847316INNOVA41 847842GS4100 850494WSP1 850747IN4100 856365ANGIO 8565961N4100 858939IR9 8593134100 8595724100 863687INV24 864255SF4100 865373SP 865541CCL5 865693CCL3 901726SP2 903CSM4100 903GS4100 904202SP1 904202SP2 904276SP 904BSSP 906485ANGIO 910907WAVAS1 915577SP1 915577SP2 918307SHIN4 918494SFSP41 918682IN41 918744JC4100 937352IN4100 9408984100 941483INNOVA41 954MW4100 956632INN4100 970247INNOVA 972335LIB 972487ANGIO1 972566INNOVA3 985867INNOVA2 989466INNOVA ECXV1406E FHORL4100 FWANG3217 MIRAMAR41 PEMBROKE4100 RADNETXV2 SLIN4100 WCATHLAB41 0853060187 0853060196 06004VAS02 06063VAS01 0856060099 SK1110VA02 E001RX08 SA1188VA03 RU1018VA03 RU1050VA03 RU1063VA01 RU1106VA02 RU1283VA01 RU1326VA01 RU1581VA01 RU2526VA01 RU2992VA01 RU3105VA01 787653INNOVA 600050VA01 NO1015VA04 NO1017VA03 NO1018VA02 NO1064VA04 BRD0411 MA1020VA01 MA1251VA01 LT4001VA02 KW1001VA03 KW1013VA01 0850060707 0850060720 0850060725 XF0160 YV0014 XF0022 XF0149 XF0150 XF0151 XF0156 XF0250 YV0001 YV0002 YV0003 YV0004 YV0005 YV0006 YV0007 YV0009 A5105151 A5123529 A5605732 A5630803 A5630803 C5603903 083016282100259 082406310005 082416040020 0828160011 0828160012 083016002000488 0850060721 IE1100VA01 HU1039VA02 00065VAS01 00084VAS02 00095VAS07 00137VAS01 00171VAS01 A9793314 R4211476 FI1015VA01 DE188442 DE641223 407953XR01 HC1819XR09 UC1129XR33 600002VA01 CS1054VA01 CS1226VA01 250370INNOVA 306766INNOVA 4163694100 416756INNOVA 514376INNOVA 514934BANGIO 519663INNOVA2 519685INNOVA 613548INNOVA3 082406010013 082406150009 082406010011 082406040022 082406070010 082406100018 082406120016 082416030007 082416040021 082416100016 082416130010 082416130011 082416130012 082416130013 082416140005 082416160005 082416160010 082416220006 BY4020VA01 2726801 BG4037XR01 190020RX09 BA4073VA01 0910063039 3882643438CTNOR
  • 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 4100/4100IQ GE Innova 4100 / 4100 IQ., 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