Events

Recall of Device Recall GE Innova 2100IQ

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

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
    44936
  • Event Risk Class
    Class 2
  • Event Number
    Z-1088-2007
  • Event Initiated Date
    2006-06-06
  • Event Date Posted
    2007-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64549
  • 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
    Fluoroscopic Imaging System, - Product Code MQB
  • Reason
    The systems do not contain a certification label on the c2 cabinet (beam-limiting control).
  • Action
    Starting on June 6, 2007, a GE service engineer will go to each affected site to affix certification labels on the affected devices.

Device

Device Recall GE Innova 2100IQ
  • Model / Serial
    00000459256BU4, 00000459553BU4, 00000459554BU2, 00000459555BU9, 00000459556BU7, 00000459557BU5, 00000460056BU5, 00000460057BU3, 00000460058BU1, 00000460059BU9, 00000460060BU7, 00000460063BU1, 00000460065BU6, 00000460066BU4, 00000460067BU2, 00000461642BU1, 00000461643BU9, 00000461644BU7, 00000461645BU4, 00000462898BU8, 00000462899BU6, 00000462900BU2, 00000462901BU0, 00000462902BU8, 00000462903BU6, 00000462904BU4, 00000462905BU1, 00000462906BU9, 00000462907BU7, 00000463613BU2, 00000463630BU4, 00000463631BU2, 00000463632BU0, 00000463633BU8, 00000463634BU6, 00000463636BU1, 00000463637BU9, 00000463638BU7, 00000463639BU5, 00000463841BU7, 00000467440BU4, 00000467441BU2, 00000467442BU0, 00000467443BU8, 00000467444BU6, 00000467445BU3, 00000467446BU1, 00000467447BU9, 00000467448BU7, 00000467449BU5, 00000467451BU1, 00000469541BU7, 00000469542BU5, 00000469543BU3, 00000469544BU1, 00000469545BU6, 00000469546BU6, 00000469547BU4, 00000469548BU2, 00000469549BU0, 00000469550BU8, 00000470643BU8, 00000470644BU6, 00000470645BU3, 00000470646BU1, 00000470647BU9, 00000470648BU7, 00000470649BU5, 00000470650BU3, 00000470651BU1, 00000470652BU9, 00000471493BU7, 00000471494BU5, 00000471495BU2, 00000471496BU0, 00000471497BU8, 00000471498BU6, 00000471499BU4, 00000471500BU9, 00000471501BU7, 00000471502BU5, 00000472676BU6, 00000477489BU9, 00000477490BU7, 00000477491BU5, 00000477492BU3, 00000477493BU1, 00000477494BU9, 00000477495BU6, 00000477496BU4, 00000477497BU2, 00000477498BU0, 00000477893BU2, 00000479230BU5, 00000479231BU3, 00000479232BU1, 00000479233BU9, 00000479234BU7, 00000479235BU4, 00000479236BU2, 00000479237BU0, 00000479238BU8, 00000479239BU6, 00000479937BU5, 00000479945BU8, 00000479946BU6, 00000479947BU4, 00000479948BU2, 00000479949BU0, 00000479950BU8, 00000479951BU6, 00000479952BU4, 00000479953BU2, 00000479954BU0, 00000482511BU3, 00000482512BU1, 00000482513BU9, 00000482514BU7, 00000482515BU4, 00000482516BU2, 00000482517BU0, 00000482518BU8, 00000482519BU6, 00000482520BU4, 00000484054BU2, 00000485072BU3, 00000485074BU9, 00000485075BU6, 00000485076BU4, 00000485077BU2, 00000485078BU0, 00000485079BU8, 00000485080BU6, 00000485081BU4, 00000487465BU7, 00000487466BU5, 00000487469BU9, 00000487470BU7, 00000487471BU5, 00000487472BU3, 00000487473BU1, 00000487474BU9, 00000491019BU6, 00000491020BU4, 00000491021BU2, 00000491022BU0, 00000491023BU8, 00000491025BU3, 00000491027BU9, 00000491028BU7, 00000491032BU9, 00000492823BU0, 00000492824BU8, 00000492825BU5, 00000492827BU1, 00000492828BU9, 00000492830BU5, 00000492831BU3, 00000494960BU8, 00000504480BU5, 00000508755BU6, 00004600057BU3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide Distribution includes: AL, AR, AZ, CA,, CO, CT FL, GA, HI, ID, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI,and WV, and countries of ; Algeria, Australia, China, Denmark, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, New Zealand, Norway, Poland, Saudi Arabia, Singapore, Switzerland, Syrian Arab Republic, Turkey, and United Kingdom.
  • Product Description
    GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. GE Healthcare Americas P.O.Box 414, Milwaukee, Wisconsin 53201, U.S.A.
  • Manufacturer
    GE Healthcare

Manufacturer

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