Events

Recall of Device Recall GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ

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
    64274
  • Event Risk Class
    Class 2
  • Event Number
    Z-0934-2013
  • Event Initiated Date
    2011-02-04
  • Event Date Posted
    2013-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115743
  • 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 imager (flat panel/digital imager) - Product Code MQB
  • Reason
    Exposed high voltage wires inside the cabinet . on a cable located in the system cabinet, two of the shrink tubings covering the 400v live cable leave an area potentially unprotected.
  • Action
    No consignee letter sent out. GE Healthcare's recall strategy was to replace the impacted cable on all affected Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ systems that were distributed. At this time, deployment of this recall is considered complete as of 9/6/2011.

Device

Device Recall GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ
  • Model / Serial
    SERIAL NUMBER 592043BU4 592676BU1 593459BU1 593465BU8 592458BU4 592673BU8 592682BU9 593059BU9 593051BU6 593475BU7 593476BU5 592049BU1 593468BU2 593054BU0 592047BU5 592042BU6 592046BU7 592459BU2 593048BU2 593056BU5 593049BU0 593063BU1 593062BU3 593464BU1 594762BU7 593473BU2 592451BU9 593460BU9 597954BU7 592456BU8 592674BU6 593052BU4 593058BU1 590867BU8 592050BU9 593064BU9 592460BU0 592457BU6 592680BU3 592455BU0 593462BU5 592678BU7 594763BU5 593055BU7 592675BU3 592452BU7 593463BU3 594385BU7
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL.
  • Product Description
    GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging || systems. || For use in generating fluoroscopic images of human anatomy.
  • 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