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-2360-2008
  • 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=72411
  • 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
    00000483707BU6 00000452932BU7 00000208/00036 00000452935BU0 00001107/00021 00000907/00004 00000208/00039 00001107/00016 00001007/00009 00000707/00001 00000907/00003 00000907/00008 00001007/00014 00000907/00010 00000907/00003 00000907/00005 00000907/00009 00000208/00035 00000907/00007 00001107/00012 00000907/00006 00001007/00011 00000907/00002 00000452928BU5 00000208/00033 00001107/00022  Unknown 00000536861BU8 00001007/60645 00001107/61044 00000907/60638 00000105/30208 00000469378BU4 00000524123BU7 00000604/10099 00000460514BU3 00000536894BU9 204110064 304110062 304110071 404110070 404110087 00000105/30033 00000105/30151 00000105/30154 00000105/30155 00000105/30202 00000105/30205 00000108/00027 00000108/00029 00000108/00030 00000108/60206 00000108/60207 00000108/60210 00000108/60673 00000108/60675 00000108/60676 00000108/60677 00000108/61091 00000108/61104 00000108/61105 00000108/61107 00000108/61109 00000108/61110 00000108/61113 00000108/61114 00000108/61115 00000108/61119 00000108/61120 00000108/61121 00000108/61124 00000108/61125 00000108/61128 00000108-60206 00000112404VE9 00000112422VE1 00000112426VE2 00000112429VE6 00000112443VE7 00000112457VE7 00000112458VE5 00000112460VE1 00000112465VE0 00000208/00038 00000208/60681 00000208/60682 00000208/60683 00000208/60685 00000307/50892 00000307/50904 00000307/50907 00000407/50167 00000407/50171 00000407/50595 00000407/50911 00000452806BU3 00000452807BU1 00000452809BU7 00000452813BU9 00000452823BU8 00000452837BU8 00000452855BU0 00000452860BU0 00000452864BU2 00000452865BU9 00000452869BU1 00000452870BU9 00000452872BU5 00000452875BU8 00000452878BU2 00000452895BU6 00000452905BU3 00000452907BU9 00000452916BU0 00000452918BU6 00000452922BU8 00000452925BU1 00000452926BU9 00000452933BU5 00000453142BU2 00000453160BU4 00000453162BU0 00000453166BU1 00000453169BU5 00000453173BU7 00000453174BU5 00000453175BU2 00000453178BU6 00000453183BU6 00000453187BU7 00000453188BU5 00000453195BU0 00000453222BU2 00000453227BU1 00000460507BU7 00000460512BU7 00000460513BU5 00000460521BU8 00000460522BU6 00000460524BU2 00000460525BU9 00000460527BU5 00000460539BU0 00000460544BU0 00000460546BU5 00000460551BU5 00000460552BU3 00000460555BU6 00000460556BU4 00000460573BU9 00000460582BU0 00000460583BU8 00000460586BU1 00000460588BU7 00000460592BU9 00000460595BU2 00000460600BU0 00000460606BU7 00000460607BU5 00000460612BU5 00000460616BU6 00000460619BU0 00000460622BU4 00000460627BU3 00000460628BU1 00000460629BU9 00000466668BU1 00000466669BU9 00000466672BU3 00000466673BU1 00000466676BU4 00000466680BU6 00000466683BU0 00000466748BU1 00000466753BU1 00000466764BU8 00000466765BU5 00000469267BU9 00000469268BU7 00000469285BU1 00000469309BU9 00000469314BU9 00000469316BU4 00000469321BU4 00000469326BU3 00000469334BU7 00000469340BU4 00000469341BU2 00000469353BU7 00000469357BU8 00000469366BU9 00000469369BU3 00000469382BU6 00000469400BU6 00000469405BU5 00000469406BU3 00000469408BU9 00000469409BU7 00000469410BU5 00000469411BU3 00000469412BU1 00000469413BU9 00000469415BU4 00000469417BU0 00000469420BU4 00000469422BU0 00000469423BU8 00000483686BU2 00000483687BU0 00000483689BU6 00000483693BU8 00000483698BU7 00000483700BU1 00000483705BU0 00000493791BU8 00000493797BU5 00000493800BU7 00000493807BU2 00000499134BU5 00000499135BU2 00000499136BU0 00000499140BU2 00000499143BU6 00000499144BU4 00000499156BU8 00000499166BU7 00000499167BU5 00000499168BU3 00000499181BU6 00000499185BU7 00000499186BU5 00000507/50923 00000507/50926 00000507/50929 00000507/50939 00000507/50941 00000507/50944 00000507/50959 00000507768BU0 00000507769BU8 00000507776BU3 00000507778BU9 00000507786BU2 00000507787BU0 00000507794BU6 00000507795BU3 00000507819BU1 00000507822BU5 00000507833BU2 00000507840BU7 00000507842BU3 00000520238BU7 00000520245BU2 00000520247BU8 00000520250BU2 00000520252BU8 00000520254BU4 00000520255BU1 00000520261BU9 00000520262BU7 00000520266BU8 00000520269BU2 00000520272BU6 00000520279BU1 00000520286BU6 00000520289BU0 00000520291BU6 00000520295BU7 00000520302BU1 00000524115BU3 00000524125BU2 00000524127BU8 00000524128BU6 00000524131BU0 00000524136BU9 00000524138BU5 00000524140BU1 00000524157BU5 00000524159BU1 00000524170BU8 00000536826BU1 00000536828BU7 00000536829BU5 00000536834BU5 00000536844BU4 00000536846BU9 00000536852BU7 00000536857BU6 00000536859BU2 00000536860BU0 00000536862BU6 00000536867BU5 00000536869BU1 00000536871BU7 00000536873BU3 00000536874BU1 00000536875BU8 00000536880BU8 00000536881BU6 00000536884BU0 00000536886BU5 00000536887BU3 00000536888BU1 00000536889BU9 00000536896BU4 00000536897BU2 00000536906BU1 00000536907BU9 00000536909BU5 00000536914BU5 00000536924BU4 00000607/30018 00000607/50600 00000607/50603 00000607/50605 00000607/50963 00000704/20114 00000707/60173 00000707/60978 00000707/60986 00000707/60989 00000707/60990 00000707/60991 00000707/60993 00000707/60994 00000807/60177 00000807/60179 00000807/60184 00000807/61004 00000807/61007 00000807/61009 00000807/61011 00000807/61015 00000807/61018 00000807/61022 00000907/00006 00000907/60192 00000907/60633 00000907/60634 00000907/60641 00001007/00010 00001007/00015 00001007/60644 00001007/61040 00001107/00013 00001107/00015 00001107/00017 00001107/00018 00001107/00019 00001107/00024 00001107/00025 00001107/00026 00001107/61045 00001107/61046 00001107/61047 00001107/61059 00001204/30032 00001204/30177 00001204/30198 00001207/00022 00001207/60198 00001207/60199 00001207/60661 00001207/61061 00001207/61062 00001207/61065 00001207/61066 00001207/61068 00001207/61069 00001207/61077 00001207/61078 00001207/61079 00001207/61082 00001207/61084 00001207/61085 00001207/61088 0000704/020110 00000907/60640 00000105/30210 00000307/50906 00001207/61074 00000307/50894 00000307/50898 00000507/50927 00000707/60985 00001107/61055 00000108/61122 00000452801BU4 00000452804BU8 00000452824BU6 00000452827BU9 00000466716BU8 00000607/50965 00000807/60624 00001107/60652 00001107/61048 00001107/61057 00000524145BU0 00000536831BU1 00000907/60190 00001207/60204 00000469384BU2 00000453133BU1 00000907/60629 00000108/61126 00000452859BU2 00000452874BU1 00000452897BU2 00000452915BU2 00000453163BU8 00000469327BU1 00000469418BU8 00000507841BU5 00000907/60191 00000536921BU0 00000108/61096 00000108/61123 00000536899BU8 00000536902BU0 00000607/50966 00000707/50972 00001207/60202 00000807/60628 00000108/60665 00000108/60667 00000108/61093 00000108/61101 00000108/61103 00000208/61130 00000307/50899 00000452830BU3 00000453144BU8 00000453145BU5 00000460535BU8 00000460567BU1 00000469304BU0 00000469332BU1 00000499158BU4 00000499159BU2 00000536883BU2 00000707/50615 00000707/60616 00000707/60996 00000807/60181 00000807/60182 00000807/60627 00000907/60187 00000907/60189 00000907/60194 00000907/60630 00000907/60642 00000907/61027 00001007/00011 00001007/60646 00001007/60648 00001007/60649 00001107/00014 00001107/60654 00001107/60655 00001107/60656 00001107/61053 00001207/61072 00001207/61075 00000108/00028 00000108/61092 00000452898BU0 00000907/00002 00000907/60188 00001007/61033 00000307/50901 00000907/60636 00000453134BU9 00000907/00004 00000907/61029 00001007/00017 00000520303BU9 00000108/61098 00000452805BU5 00000907/60632 00001107/61051 00000108/60672 00000108/61097 00000453210BU7 00000460534BU1 00000499184BU0 00000524146BU8 00000807/61003 S0000607/50962 5126893 00000108/00031 00000108/00032 00000108/61100 00000108/61112 00000112430VE4 00000112435VE3 00000112444VE5 00000112455VE1 00000208/00034 00000407/50169 00000452796BU6 00000452847BU7 00000452876BU6 00000452877BU4 00000452902BU0 00000452910BU3 00000452912BU9 00000452924BU4 00000453212BU3 00000453214BU9 00000466741BU6 00000466750BU7 00000483692BU0 00000499171BU7 00000499174BU1 00000499176BU6 00000499179BU0 00000499187BU3 00000499190BU7 00000520300BU5 00000536898BU0 00000607/50968 00000707/50608 00000907/60186 00000907/60193 00001107/00023 00001107/61058 00000499160BU0 00000507789BU6 00000524141BU9 00000108/60205 00000907/60195 00001107/60659 00001007/00016 00001007/61037 00000499161BU8 00001207/60197 00000707/60987 00000907/61030 00001007/61032 00000520304BU7 00000112453VE6 00000453176BU0 00000453181BU0 00000466728BU3 00000469283BU6 00000493798BU3 00000707/60618 00000807/51008 00000807/60619 00000807/60620 00000108/60666 00000407/50594 00000407/50599 00000507/50943 00000507/50947 00000507/50948 00001107/61042 00000452913BU7 00000499177BU4 00000807/50178 00001107/00020 00001107/00020 00000507/50925 and 00000536847BU7
  • 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 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. 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