Events

Recall of Device Recall Digital Fluoroscopic Imaging System

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
    48961
  • Event Risk Class
    Class 2
  • Event Number
    Z-2359-2008
  • Event Initiated Date
    2008-06-24
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72410
  • 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 X-ray system - Product Code MQB
  • Reason
    Ge healthcare has become aware of 2 potential conditions that could occur with the mavig gd monitor suspension that is used with advantx-e, innova 2000, 21000iq, 3100/3100iq, 4100/4100iq and 2121 iq/3131iq cardiovascular systems. the two conditions include 1). due to insufficient securing of the connecting elements, the lcd vertical monitor support may disengage from its arm and fall on the tab.
  • Action
    The consignees were sent a "GE Urgent Medical Device Correction" letter dated May 2008. The letter was addressed to Manager of Radiology/Cardiology; Radiologists/Cardiologists and; Biomedical/Clinical Engineering. The letter described the problem, affected products, short term user recommendations, GE Healthcare resolution plan and contact information. Contact GE Healthcare at 1-262-544-3894 for assistance.

Device

Device Recall Digital Fluoroscopic Imaging System
  • Model / Serial
    00001104/20163 00000453208BU1 00000604/20009 00000452923BU6 00001104/20026 1003000011 106100046 304110016 00000483694BU6 1103100017 00000483695BU3 00001004/20125 00000452904BU6 00000905/40049 50410007 00000904/20132 00000904/20010 00001103/20127 00000404/10003 00000466738BU2 1203100011 00000453217BU2 00001103/00006 00000045295BU1 1203100009 120340010 00000461244BU6 00000499182BU4 00000453148BU9 00000460515BU0 00000461241BU2 00001204/30194 00000453153BU9 00000705/40244 00000452906B01 00000452906BU1 00000453194BU3 00000453146BU3 00000604/20019 00000466737BU4 00001107/61054 00000453132BU3 00000453154BU7 00000453156BU2 00000453161BU2 00000469231BU5 00000452821BU2 00000461245BU3 00000112406VE4 00000461242BU0 00000453152BU1 00000461246BU1 00000461247BU9 00000461243BU8 00001107/00019 00000469389BU1 00000452835BU2 00000466670BU7 00000469265BU3 00000466721BU8 00000453149BU7 and 00000453216BU4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA: AR, CA, GA, IN, LA, MA, MD, MO, NJ, NM, NV, NY, OH, OR, PA, SC, TN TX, WI, AL, AZ, CO, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, ME, MI, MN, MS, MT, NC, ND, NE, NH, OK, OR, PA, SD, UT, VA, VT, WA,WV, KY, and WI OUS: ALGERIA AUSTRALIA AUSTRIA BELARUS BELGIUM BRASIL CANADA CHILE CHINA CHINA COLUMBIA CZECH REPUBLIC DENMARK DV EGYPT FINLAND FRANCE GEORGIA GERMANY GREECE GUATAMALA HONG KONG HUNGARY INDIA INDONESIA IRAN IRAQ IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LATVIA LEBANON MACEDONIA MALAYSIA MEXICO MOROCCO NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVAKIA SPAIN SUDAN SWEDEN SWITZERLAND SYRIA TAIWAN TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VENEZUELA
  • Product Description
    Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.
  • 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