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-2361-2008
  • 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=72412
  • 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
    00000108/61094 1003100013 0000010031000L 00000452818BU8 00000704/20108 1103100019 1103100019 00000404/10070 104100053 104100051 104100057 00000452834BU5 1104120128 00000452889BU9 00000452890BU7 00000524134BU4 00001104/20167 909110081 1103100025 00000452863BU4 000005041A0050 0000904/201135 00000405/40184 00001104/20157 00000704/20105 00000452867BU5 00000604/10092 00000452856BU8 1103100021 00000569/100S1 204110065 00000452886BU5 00000607/60971 00000469421BU2 106100066 1003100009 00000453141BU4 00001204/30186 00001104/20172 00000466711BU9 00000704/20102 00000469228BU1 1103100017 00000707/50172 30177 100300002 110300023 1103100026 00001003/00002 00001103/00023 00000452894BU9 609110902 00000304/20129 00000404/10078 00000704/20112 00000105/30149 00000466679BU8 104100050 00000707/60998 00000469313BU1 00000307/50908 00000807/61002 00000805/40289 00000452817BU0 00001207/61076 00000105/30150 00000469278BU6 00001004/20007 00001207/60203 00000469262BU0 00001207/61070 00000524144BU3 00000807/61012 00000469252BU1 00000707/50611 00000524120BU3 00000807/61005 00000805/40263 00001107/60651 00000405/40252 00001003/00006 00000453164BU6 00001204/30189 204110049 00000536915BU2 00000452844BU4 00001204/30200 00000507826BU6 00000536925BU1 00000460519BU2 00000466701BU0 00000452849BU3 1203100025 00000104/00052 00000452839BU4 00000536863BU4 00000460617BU4 00000452815BU4 00000452838BU6 1203100041 304110072 24110061 204110061 00000466746BU5 00001003/00012 00001203/00035 00000453138BU0 110360007 00000104-00014 00001004/20150 00000604/20095 00000604/20098 00000704/20111 00000453136BU4 00000453179BU4 00000452868BU3 00000452797BU4 00000461248BU7 00001204/30197 00000104/00044 00001204/30147 00000460593BU7 1203100038 00000466744BU0 00000452810BU5 704120118 00000452819BU6 00000507/50936 00000604/10087 00000112450VE2 00000460543BU2 00001003/00008 00000452816BU2 00000499172BU5 and 00000499169BU1
  • 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
    Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment..
  • 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