Events

Recall of Innova 2121IQ/31311Q Biplane Cardiovascular 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-0407-2011
  • 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=95070
  • 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 2121IQ/31311Q Biplane Cardiovascular Imaging System
  • Model / Serial
    2121IQ 2036882121 4146492121 05448VAS01 206598UWBP 214590EP2121 215576INNOVA2 253627INNOVA5 301295CATH 304526INNOVABP 3108252121A 3108252121B 316268BIPLANE 319272EP 4105502121 410614CV1 410614CV2 541743CL5 610526LAB3 610954BP1 612273INNOVA3 617636IN2121 713794LAB11 857307IN12121 857307IN22121 857307IN32121 904202WCL1 936WH2121 FHORLEP4 FHORLEP5 IE1100VA03 MCDEP VAD2121  3131IQ 4144473131 00026VAS01 00243VAS02 00440VAS04 10307VAS01 2197383131 281637SL3131 301295EP 309655FSP2B 309655FSP4A 317338PV4 410740CV 509474BIP 5135843131 540776LGVAS2 541382BP 542120XR02 561495DLBIP 561548BIP 561881BP1 615222BIH 617525IN13131 6263973131 630933INVLAB4 650493BIPL 713794LAB8 718579INNOVABP 773RES3131BP 814877BP 816932SL3131 817465AR3131 8184093131 985867INNOVA31 COR373252 COR373295 EG1000VA01 N4192939
  • 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 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. || The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography 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. These 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