Events

Recall of GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova

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
    66254
  • Event Risk Class
    Class 2
  • Event Number
    Z-0021-2014
  • Event Initiated Date
    2013-08-16
  • Event Date Posted
    2013-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121897
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Ge healthcare has become aware of a potential safety issue involving missing screws in the overhead video monitor suspension of the advantx, innova 2000, innova 2100iq, innova 3100, innova 3100iq, innova 4100, innova 4100iq cardiovascular x-ray imaging systems.
  • Action
    Consignees were sent on 8/12/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 12, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology /Cardiology /Surgery Department and Radiologists /Cardiologists /Surgeons. The letter described the Safety Issue, safety Instructions, Affected Product details, Product Correction and Contact Information (US 800-437-1171, Japan 0120 055 919).

Device

GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SLOVAKIA, SPAIN, SWEDEN, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, and VENEZUELA.
  • Product Description
    GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. || Intended for general purpose diagnostic fluoroscopy and radiography studies.
  • 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