Events

Recall of Innova 2100IQ (The Digital Fluoroscopic Imaging System)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, 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
    56967
  • Event Risk Class
    Class 2
  • Event Number
    Z-0408-2011
  • Event Initiated Date
    2009-08-05
  • Event Date Posted
    2010-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95071
  • 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
    Solid state x-ray image (flat panel/digital imager) - Product Code MQB
  • Reason
    Ge healthcare has become aware of a potential issue regarding innova systems with ge fluoro ups 20kva that may impact patient safety. ge fluoro ups 20kva (uninterrupted power supply) is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. once power is restored, the equipment power will be returned to the main hospital power. ups fluoro ba.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter on August 5, 2009 to all Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letter was dated August 4, 2009, and described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For questions regarding this recall call (262) 548-2731.

Device

Innova 2100IQ (The Digital Fluoroscopic Imaging System)
  • Model / Serial
    2100IQ 00052VAS03 00052VAS04 00060VAS02 00060VAS03 00109VAS01 00109VAS02 00109VAS03 00109VAS04 00192VAS04 00192VAS05 00440VAS02 00463VAS06 00463VAS06 05217VAS02 05451VAS01 0853060197 10507VAS01 17005VAS01 20001VAS02 201447LAB1 202745EP 202782LABC 208227CATH1 208367INNOVA 208381CCL1 212305CATH1 212604INNOVA1 214947MINNOVA 214947MINNOVA2 215453INNOVA21 219932DCL2 251435ICV3 251435ICV7 252384CATH1 253627INNOVA1 253SAHINNOVA 262687CL2 303629EP2 304526INNOVA 308865GIN1 310825INNOVA21 317338CL3 317338EP1 317355INNOVA3 318449INNOVA3 330363LAB3 330375LAB2 336538ARCL 336832MCCL6 34009VAS06 35049VAS01 360456XCL4 402559UCA 402559UCC 402559UCD 405604D2100 407321INCL2 408559INV1 409938INV21 410368INNOVA1 410554INNOVA1 410554INNOVA2 410554INNOVA3 410554INNOVA4 4107872100 412367LAB2 414291CL2 414649INNOVA2 417269SCLA 423495MCATH1 4436432100 479441EP 503561CL1 503561CL4 508335INNOVA 508422IN21 508941IN21 509575YM2100 516562INNOVA3A 541677MINNOVA2 541743CL3 541789CV1 553003XR01 561548ET2 570476EP1 570476INNOVA21 573761SMC2 574535IN21 600010VA01 603663CMCD 603882CATH1 604875AINNOVA2 608775NOVA1 608775NOVA2 609267IN2100 610250INNOVA1 610250INNOVA3 610645LAB10 610770INNOVA21 610983INNOVA2 610988INNOVA5 612273INNOVA2 615284CV3 615342CL1 615342CV3 615446CV1 615846STJV 619552INNOVA2 622223XR01 6263972100 630856H21EP 650369SV4 661327INNOVA1 661327INNOVA2 661BHINNOVA1 7023602100 704384CLEP 706291CLIN1 706774HT3 706774HT4 706774HT6 707443INNOVA 707445INNOVA1 71004VAS01 713375U2100 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727521CATH2 727869CCL2 727869EP5 732324INN1 732776CATH4 734769IN1 760940INNOVA2 760JFK2100 770HMCCL1 775982INN2100 785354HRTEP 803256PCL5 8053702100 814452EP 815759CARDIAC1 816347SLE2100 817329BG2100 8184092100 828213IN21 828315FEP 843692CATH3 843724CL1 843724CL2 843724CL3 843724EP1 843797EP 845368LAB1 845368LAB2 847316INNOVA1 847316INNOVA2 856853IN2100 857307IN421 864255SFCL1 864255SFCL2 865693CCL 865693CCL2 865977CCL 901765EP 904597CATH 910343EP1 910343EP2 910343NHIN3 916781INNOVA2 937208INNOVA2 949250I21 954735CL2 954987CCL7 954987CCL8 954987CL4 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA A004RX01 A020RX13 A147111802 A5164510 A5189718 A5220710 A5330714 A5333036 A5800506 AO1001VA01 AO1001VA01 C5123625 C5346705 D5345903 FEB52055 FEG35027 FHORLCL04 FHORLEP2 FHORLEP3 HC4348XR02 HC4480XR05 IE1077VA01 LGH2100EP M181374801 M4183841 M4183841 ME612436 NG1043VA01 NO1009VA03 PER00218 PL1101VA03 PRESBYDEP RU1047VA02 RU1295VA01 RU3301VA01 RU3312VA01 SD1038VA01 TN1027VA02 UPW21603 ZA1077VA03
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK ,OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI and the countries of ANGOLA, BELARUS, BULGARIA, CANADA, EGYPT, FRANCE, GERMANY, HUNGARY, IRELAND, MEXICO, ITALY, NIGERIA, NORWAY, POLAND, PORTUGAL, RUSSIAN FEDERATION, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, TUNISIA, TURKEY, and the UNITED KINGDOM
  • Product Description
    Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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