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-2357-2008
  • 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=72408
  • 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
    00000466713BU5 00000466705BU1 00000524119BU5 00000536916BU0 00000112428VE8 00000460509BU3 00000507823BU3 00000460516BU8 00000469271BU1 00000460505BU1 00000460528BU3 00000466687BU1 00000536866BU7 00000405/40253 00000466707BU7 00000307/50880 00000520248BU6 00000460549BU9 00000307/50896 00000469345BU3 00000112416VE3 00000466740BU8 00000460554BU9 00000469342BU0 00000466739BU0 00000466743BU2 00000466677BU2 00000460504BU4 00000466762BU2 00000307/50866 00000460623BU2 00000407/50914 00000536903BU8 00000707/60983 00000507796BU1 00000524158BU3 00000469363BU6 00000520259BU3 00000536827BU9 00000707/60999 00000466754BU9 00000493790BU0 00000520267BU6 00000112421VE3 00000493801BU5 00000407/50170 00000469344BU6 00000452845BU1 00000112418VE9 00000469335BU4 00000112431VE2 00000807/61017 00000469351BU1 00000460631BU5 00000469312BU3 00000452829BU5 00000520264BU3 00000536837BU8 00000605/00051 00000460609BU1 00000520276BU7 00000112419VE7 00000469370BU1 00000469358BU6 00000493805BU6 00000524117BU9 00000460520BU0 00000466675BU6 00000460511BU9 00000483699BU5 00000536839BU4 00000460615BU8 00000469328BU9 00000207-50843 00000466751BU5 00000469263BU8 00000507/50938 00000524147BU6 00000452812BU1 00000460569BU7 00000452921BU0 00000453224BU8 00000466767BU1 00000460503BU6 00000206/40463 00000524124BU5 00000460597BU8 00000407/50916 40372 00000452901BU2 404110077 00000466684BU8 00000536876BU6 00000536850BU1 00000536913BU7 00000466756BU4 00000469269BU5 00000507813BU4 00000112405VE6 00000112410VE6 00000460576BU2 00000466685BU5 00000466714BU3 00000466671BU5 00000536836BU0 00000108/60209 00000108/61090 00000707/60992 00000452836BU0 00001207/61063 00000907/60631 00000460585BU3 00000460563BU0 00000536904BU6 00000536922BU8 00000469372BU7 00000112447VE8 00000207/50856 00000460562BU2 00000520294BU0 00000707/60614 00000466674BU9 00000452840BU2 00000466734BU1 00000469299BU2 00000452826BU1 00000466700BU2 00000460532BU5 00000452841BU0 00000112452VE8 00000469302BU4 00000469244BU8 00000453158BU8 00000466735BU8 00000469224BU0 00000469282BU8 00000112400VE7 00000607/50602 00000469297BU6 00000466717BU6 00000524113BU8 00000507/50957 00000452927BU7 00000112436VE1 00001007/61039 00001007/61038 00000493808BU0 00000460510BU1 00000469272BU9 00000466681BU4 00000469288BU5 00000807/50176 00000520293BU2 00000469289BU3 00000469294BU3 00000469256BU2 00000469275BU2 00000460589BU5 00000536838BU6 00000460538BU2 00000466752BU3 00000307/50881 00000520274BU2 00000507/50950 00000520257BU7 00000524135BU1 00000507781BU3 00000507775BU5 00000536865BU9 00000707/50970 00000524161BU7 00000507797BU9 00000507784BU7 00000469401BU4 00000450567BU1 00000524143BU5 00001107/61052 00000469245BU5 00000806/00082 00000907/00156 00000460540BU8 00000460531BU7 00000460605BU9 00000112449VE4 00000607/50967 00000466730BU9 00000460526BU7 00000507/50922 00000469375BU0 00000460542BU4 00000469325BU5 00000499146BU9 00000499147BU7 00000520292BU4 00000469238BU0 00000460553BU1 00000469257BU0 00000520298BU1 00001107/61050 00000469259BU6 00000520258BU5 00000466747BU3 00000493803BU1 00000536891BU5 00000907/60637 00001107/60657 00000469399BU0 00000407/50586 00000407/50590 00000407/50596 00000469276BU0 00000507837BU3 00000469248BU9 00000507830BU8 00001207/60664 00000507838BU1 00000407/50165 00000520270BU0 00000469261BU2 00000507788BU8 00000707/50610 00000536923BU6 00000466742BU4 00000536854BU3 00000469290BU1 00000524150BU0 00000469281BU0 00000469258BU8 00000499178BU2 00000507772BU2 00000483696BU1 00000452934BU3 00000493794BU2 00000499180BU8 00000536832BU9 00000452914BU5 00000452908BU7 00000407/50164 00000483691BU2 00000452900BU4 00000807/60183 00000112456VE9 00000469333BU9 00000469387BU5 00000499154BU3 00000707/60980 00000469307BU3 00000466697BU0 00000469233BU1 00000524133BU6 00000112446VE0 00000707/50609 00000466731BU7 00000466718BU4 00000307/50882 00000460620BU8 00000469396BU6 00000524172BU4 00000469386BU7 00000524171BU6 00000507836BU5 00000707/60984 00000707/60617 00000469324BU8 00000707/50976 00000452831BU1 00000520240BU3 00000307/50889 00000469284BU4 00000520253BU6 00000607/50604 00000507839BU9 00000507/50952 00000469360BU2 and 00000307/50909
  • 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 2100IQ Versatile Cardiac and Vascular 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