Events

Recall of Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE

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-0409-2011
  • 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=95072
  • 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 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE
  • Model / Serial
    3100IQ 01224VAS04 01367VAS02 2014183100 202782LABB 2035763100A 2036883100 205783BCL5 205877CCL1 205877CCL2 207879CL131 209334LINNOVA1 215576INNOVA1 2197573100 229312INOV1 251435ICV6 251633PROV 2538483100 262687CL3 270688I2100 2815993100 303629EP 308865GIN2 310825INNOVA31 314768SMCL1A 316689INNOVA31 316962WCVC1 316962WCVC2 317736CL1 318254CL 318798CL1 325428CATH1 325428CATH3 336832MCPV 337374INNOVA 352333CV3 352401CATH2 360456XCL3 360SJ3100 402559UCB 404686CRI3 405372S3100 405604D3100 405840OIC3100S 406447VAIN3 4082593100 412232A 412623A 412623C 413582C3100 414447CL1 415925INV1 417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 503561CL3 504903INNOVA31 508941IN1 510797INV8 512901NI3100 541382CV3 541472CV1 541677MINNOVA1 541743CL6 561694IN1 570476INNOVA31 573458CL1 573AMC3100 58002VAS01 6012883100CV2 603421PCL 603580ECL1 606216CATH1 606216CATH2 606439INNOVA2 606678INNOVA 6067593100 609267IN3100 609597IN3100 609757IN3100 610526LAB1 610526LAB2 610595CL1 610645LAB6 610770INNOVA31 610954INNOVA1 610983INNOVA1 617754IN31 620225INNOVA31 6263973100 630312B31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 650938LY31 6619483100 662377CV2 662377CV4 678957INNOVA 704355PCL 704355RM2 704384CATH2 704384PHHCL 704384PHMCATH 704384PHMCATH 704878CL31 706481CCL 706774HT8 708WESTSUB3100 7133933100 717270INNOVA31 717544GECATH5 717782INNOVA31A 718245UNITY 718250CATH1 718270INNOVA1 718780CATH2 727521CATHOP 727725CATH2 732776CATH2 732776CATH6 760242CATH2 760323DRINNOVA 770991CL1 770HMCCL2 772LWCL2 785354S3100 803255CL1 803256LAB2 803776CL1 804285CATH1 8053703100 808485INNOVA 812237THR31 815226OSFLAB1 815344CARDIAC3 815756KCHSPEC 8184093100 8185023100 8189813100XX 843674INNOVA2 843692CATH2 847362CONCATH4 8508573100 850862IN3100 863687CL31 864255SFCL3 864512CL1 864512CL2 864512CL4 865693CCL1 903HC3100 903UT3100 910343NHIN4 912486CATH1 918333JPIN2 919731WMINOV 919784REP1 9202623100 9284533100 9287883100 931459CV1 BG4549VA02 BY4067VA02 DPM32143 DR3100 FHORLCL7 FPG30528 HC4348XR01 KMC3100 MARTINSVILLE310 MCDCATH2 MCDCATH4 NO1000VA03 NPV15952 PER08306 PL1491VA01 PL1553VA01 PL1650VA02 PL1688VA01 RU1013VA02 RU1295VA02 RU1295VA03 RU1295VA04 RU1346VA01 RU1453VA01 RU1475VA01 RU1550VA02 RU1618VA01 RU2076VA02 RU2442VA01 RU2558VA01 RU2741VA03 RU2747VA01 RU2886VA01 RU3053VA01 RU3136VA01 RU3230VA01 RU3230VA02 RU3253VA01 RU3285VA01 RU3317VA01 RU3328VA01 RU3331VA01
  • 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 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, 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 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