Events

Recall of Device Recall Innova 4100/4100IQ

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
    49539
  • Event Risk Class
    Class 2
  • Event Number
    Z-0475-2009
  • Event Initiated Date
    2008-01-30
  • Event Date Posted
    2009-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73764
  • 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
    Image-intensified fluoroscopic x-ray system - Product Code MQB
  • Reason
    Software error, computer: ge healthcare has became aware of an issue with error management affecting the innova 2100, 3100/3100 iq & 4100/4100iq. it was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no x-rays being emitted. but the message "acquisition in progress" was displayed on the dl monitor, even after the foot switch was r.
  • Action
    Consignees sent a "GE Urgent Medical Device Correction" letter dated February 28, 2008. The letter was addressed to Hospital Administrators/Hospital Risk Management Department/Managers of Radiology-Cardiology/ Radiologists-Cardiologists. The letter described the affected products, safety Issue, short term recommendations, long term solution and contact Information. The first batch of letters was received by customers on 5/28/08. For further information, please contact GE Healthcare at 262-544-3894

Device

Device Recall Innova 4100/4100IQ
  • Model / Serial
    "0002651236A  813745INTV" 0002701957A 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 SHOWCASE4100 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 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 0002520549AX 252816INNOVA 309343CSP1A  309655FSP3A  802295VALCA  190020RX09 082406070010 082406310005 082416030007 082416040020 082416100016 082416130020 082416130021 082416130025 082416220006 82406040022 82406120016 82416130010 82416130011 82416130013 82416140005 82416160005 82416160010 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA 416756INNOVA 514376INNOVA 514934BANGIO 519663INNOVA2 519685INNOVA 204787INNOVA1  CS1054VA01 HC0220XR07 407953XR01 487692XR01 UC1129XR33 FI1015VA02 FI1015VA01 M1230007 N4192927 R4211476 M4505274  00490VAS02 01278VAS01 10091VAS01 00095VAS07 00137VAS01 00171VAS01 00860VAS01  HU1039VA02 IE1100VA01 IL1043VA01 083006202101017 A5102671 A5163317 A5605732 A5105151 C5603903 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 XF0022 XF0149 YV0001 YV0002 YV0004 0850060718 0850060720 0850060721 0850060722 0850060725 850060707 KW1001VA03 KW1001VA04 KW1018VA04 KW1013VA01 LB1037VA01 MA1020VA01 BRD0411 NO1015VA04 600042VA02 787620IN4100 787653INNOVA 600152VA01 RU2714VA01 RU2992VA01 RU1050VA03 RU1018VA03 RU1106VA02 SA1005VA06 E001RX08 0002603739 0002603828 06004VAS02, and  853060187
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA including 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; the United States territory of Puerto Rico; and countries of ALGERIA, AUSTRALIA, BELARUS, BELGIUM, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ,FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND,NORWAY, PANAMA, POLAND, PORTUGAL RUSSIAN FEDERATION SAUDI AR ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SUDAN, SWEDEN SWITZERLAND, SYRIA, TAIWAN, TURKEY UNITED KINGDOM, and VENEZUELA.
  • Product Description
    GE Innova 4100 /4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) 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.
  • 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