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-2356-2008
  • 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=72406
  • 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
    00000536885BU7 00000524151BU8 00000807/61010 123100037 1203100026 1203100029 00000507807BU6 00000520244BU5 00000460530BU9 00000469400bu6 00000452842BU8 00000112420VE5 00000469349BU5 00000469380BU0 00000307/50876 00000524122BU9 00000453185BU1 00000460590BU3 00000105/30212 9110080 00000469377BU6 00000504/10092 00000704/20116 00000507774BU8 00000493795BU9 00000307/50891 00000507773BU0 00000460632BU3 00000112399VE1 00000407/50915 00000483688BU8 704120117 00000536842BU8 00000112423VE9 00001004-20153 00000524162BU5 00000536835BU2 00000048698BU7 00000507811BU8 00000807/61019 00000507/50956 00001204/30190 00000507817BU5 00000469368BU5 00001204/30187 00000452891BU5 00000452866BU7 00000707/60982 00001204/30191 00000493809BU8 00000112407VE2 00000112409VE8 00000499188BU1 00000499133BU7 00000507792BU0 00000536845BU1 00000469343BU8 00000524118BU7 00000536848BU5 00000460550BU7 00000524167BU4 00000469355BU2 00000483704BU3 00000520268BU4 00000307/50878 00000407/50910 00000469359BU4 00000112427VE0 00000469354BU5 00000493804BU9 00000604-10104 00000507814BU2 00000453182BU8 00000307/50883 00000460580BU4 00000453184BU4 0000M04/200013 304110059 00000707/60979 00000507770BU6 00000499138BU6 00000307/50900 00000483685BU4 00000520280BU9 00000499152BU7 00000460557BU2 00000469410NU5 00000307/50872 00000536892BU3 00000112414VE8 00000460621BU6 00000520265BU0 00000524152BU6 00000807/61020 00000204/10054 00000499175BU8 00000466696BU2 00000493796BU7 00000507791BU2 00000499157BU6 00000524156BU7 00000536910BU3 00000524153BU4 00000507804BU3 1204930184 00000907/60185 00001004/20148 00000469352BU9 000000M0420A3A 00000306/40566 00000499153BU5 00000453180BU2 00000520271BU8 00000466723BU4 00000105/30152 00000904/20011 00001004/20143 00000507/50940 00000704/20106 00000536855BU0 00000536856BU8 00000452884BU0 00000520239BU5 00001104/20029 00000466690BU5 304110067 00000452853BU5 00000453191BU9 00000469329BU7 00000460626BU5 00000536830BU3 00000499132BU9 00000460602BU6 00000112417VE1 00000704/10107 00000507809BU2 00000452846BU9 00000107/50809 00000536851BU9 00000112425VE4 00000466712BU7 00001005/40426 00000460610BU9 00000112432VE0 00000307/50905 00000520296BU5 00000469347BU9 00000460603BU4 00000507/50935 00000452850BU1 00000307/50893 1203100022 00000536901BU2 00000407/50913 00000452857BU6 00000460559BU8 00000112433VE8 00000536849BU3 00000107/50819 00000536905BU3 00000807/61013 00000105/30213 00000520246BU0 00000520301BU3 00000460614BU1 00000105/30204 00000904/20136 00000507810BU0 00001003/00013 00000507802BU7 00000452887BU3 00000407/50168 00000907/61025 00001007/61036 00000520249BU4 00000452852BU7 00000707/60174 00001107/61043 00001107/61049 00000520275BU9 00001207/61086 00000453189BU3 00000807/61016 00001007/61031 00000108/61111 00001207/61083 00000452825BU3 00000108/61108 00000304/10062 00001007/61041 00000460587BU9 00000460571BU3 00000807/61021 00000452858BU4 00000807/61023 00000704/20104 00001207/61089 00000536890BU7 00000904/20139 00000520282BU5 00000469361BU0 00000707/60977 00000507803BU5 00000483703BU5 00000520288BU2 00000460624BU0 00000407/50912 00000469395BU8 00000307/50903 00000404/10085 00000507779BU7 00000499155BU0 00000469300BU8 00001104/20156 00000460599BU4 00000407/50920 00000452893BU1 00000307/50865 00000520235BU3 00000469239BU8 00000469247BU1 00000469416BU2 00000499170BU9 00000607/50964 00000466689BU7 00000466758BU0 00000507828BU2 00000469235BU6 00000536920BU2 00000607/50969 00000469293BU5 00000469277BU8 00000460517BU6 00000466715BU0 00000452822BU0 00000469242BU2 00000466732BU5 00000466698BU8 00000469318BU0 00000105/30153 00000807/60626 00000707/50607 00000466694BU7 00000469286BU9 00000407/50589 00000507829BU0 00000453151BU3 00000407/50592 00000469249BU7 00000407/50597 00000469260BU4 00000466725BU9 00000452833BU7 00000452820BU4 00000507831BU6 00000466729BU1 00000466708BU5 00000499163BU4 00000607/50606 00000536908BU7 00000453137BU2 00000807/60625 00000453157BU0 00000507808BU4 00000460565BU5 00000466720BU0 00000904/20133 00000469419BU6 00000536853BU5 00000507782BU1 00000460547BU3 00000507790BU4 00000460574BU7 00000112411VE4  00000407/50919 00000507/50958 00000524149BU2 00000907/61026 00000112442VE9 00000407/50166 00000108/61118 00000460548BU1 00000536919BU4 00000707/60997 00000707/50973 00000520260BU1 00000453143BU0 00000469301BU6 00000507785BU4 00000469255BU4 00000453147BU1 00000460541BU6 00000524126BU0 00000507/50960 00000493806BU4 00000499139BU4 00000453215BU6 00000507/50942 00000453171BU1 00000520297BU3 00000483690BU4 00000536841BU0 00000469254BU7 00000453209BU9 00000452911BU1 00000466759BU8 00000520236BU1 00000536879BU0 00000452881BU6 00001107/61056 00000112451VE0 00000524142BU7 00000307/50867 00000507/50933 00000507/50949 00000469376BU8 00000604/10089 00000520256BU9 00000469374BU3 00000407/50917 00000507/50934 00000507/50955 00000520284BU1 00000469229BU9 00000452802BU2 00000466692BU1 00000466726BU7 00000707/50612 00000407/50593 00000536893BU1 00000466722BU6 00000460529BU1 00000469319BU8 00000304/20127 00000499137BU8 00000524132BU8 00000407/50588 00000469270BU3 00000507/50945 and 00000507/50946
  • 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
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • 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