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-2358-2008
  • 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=72409
  • 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
    00000469348BU7 00000536877BU4 404110063 00000452883BU2 00000504/10096 00000460596BU0 00000469365BU1 00000704/20115 704120114 00000536912BU9 00000460572BU1 00000052416BU0 00000460630BU7 00000307/50895 120310008 00001104/20158 00000507/50928 00000460594BU5 00000452882BU4 00000453177BU8 00000461253BU7 00000307/50879 20116 00001004/20116 00000307/50884 1003100012 00000536843BU6 00000469338BU8 00000112413VE0 50410084 00000452854BU3 00000453150BU5 00000453167BU9 00000524168BU2 904120023 00000452892BU3 00000112412VE2 00000524121BU1 00000469322BU2 00000112461VE9 00000507/50921 00000507767BU2 00000469371BU9 00000112408VE0 00000905/40399 00000453140BU6 00000907/61022 00001003/00003 00000469364BU4 1203100039 00000452885BU7 00000469346BU1 404110064 00000452862BU6 00000507812BU6 00000499183BU2 00000499131BU1 00000483701BU9 00000452873BU3 1203100032 00000466706BU9 0000066706BU94 00000452871BU7 00000536900BU4 00000112403EV1 00000112403VE1 1203100034 1003 00000453165BU3 00000469337BU0 404110079 00000469264BU6 00000466763BU0 00000520277BU5 110310015 00000469330BU5 00000524129BU4 00001004/20145 00000404/10086 104100047 304110017 00000GD60U6-GE 00000904/20130 00000453213BU1 00000469394BU1 1103100020 00000461251BU1 1203100033 110420162 00000469367BU7 00000466688BU9 00000469381BU8 00000469350BU3 00000460560BU6 504110085 00000112397VE5 00000307/50868 00000507832BU4 00000307/50877 00000452828BU7 00000524154BU2 00000GD60U4-GE 00000469407BU1 904 00000524163BU3 00000460611BU7 00000466709BU3 00000460579BU6 00000104/00046 00000461252BU9 00000460568BU9 0000CA04110576 00000112434VE6 00000466755BU6 00000704/20106 00000520281BU7 00000499151BU9 00000469227BU3 00000469240BU6 00000460591BU1 00000104/00042 1204130176 00000499150BU1 00000507805BU0 00000452848BU5 604120099 00000307/50886 00000105/30203 00000105/32203 00000452880BU8 00000907/60635 1204130198 00000307/50885 00000469310BU7 00000804/20123 00001003/00007 1003100004 00000507815BU9 00000493792BU6 00000105/30201 00000460570BU5 00000507/50937 00000707/60995 00000461250BU3 00000524155BU9 00000507771BU4 00000524137BU7 00000452861BU8 00000507818BU3 00000104/00048 00000404/10074 00001204/30196 00000112398VE3 00000520251BU0 00000520278BU3 00001207/61080 00000507766BU4 00000805/40266 00000469317BU2 00000404/16671 00001207/61071 00000108/61116 00001207/60662 00001207/61067 00001104/20129 00000807/61014 00000108/61106 00000524114BU6 00000452811BU3 00001207/61087 00001007/61035 00001207/61064 00000460601BU8 00001207/60196 00001207/61081 00000453211BU5 00000469273BU7 00000108/61099 00000460577BU0 00000466745BU7 00000404/10066 00000707/60981 00000452879BU0 00000707/61001 00000453170BU3 00001004/20119 00001007/61034 00000108/61095 00000707/60988 00000707/61000 00001004/20146 00000460618BU2 00001207/60200 00000536872BU5 00000507/50931 00000507/50932 00000520299BU9 00001206/30188 00000507793BU8 00001104/20170 00000307/50888 00000536917BU8 00000524164BU1 00000452800BU6 00000507827BU4 00000469305BU7 00000520242BU9 00000507/50951 304110070 00000536832BU1 00000469393BU3 00001203/00034 00000112438VE7 00001203/00030 00000460566BU3 00000604/20097 00000469379BU2 00000507/50954 00000807/60622 00000807/61006 00000453135BU6 00000507/50953 00000407/50587 00000469391BU7 00000460575BU4 00000707/50975 00001104/20134 00000499165BU9 00000469241BU4 00000469253BU9 00000466761BU4 00000499189BU9 00000469331BU3 1204130137 00000499142BU8 00000108/60208 00000112454VE4 00000493796BU3 00000112401VE5 00000407/50918 00000469339BU6 00000507824BU1 00000452803BU0 00000507/50930 00000208/61132 00000404/10074 00000466703BU6 00000524130BU2 00000524160BU9 00001107/61060 00000507799BU5 and 00000807/60623
  • 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 4100 / 4100 IQ. , 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