Device Recall GE

Fabricant

  • Adresse du fabricant
    General Electric Med Systems, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA

399 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Mfg Lot or Serial # SED12394685GA SED12394688GA SED12404710GA SED12404711GA SED12404713GA SED12404716GA SED12404718GA SED12404720GA SED12404721GA SED12404722GA SED12404723GA SED12404725GA SED12445258GA SED12445259GA SED12445261GA SED12445262GA SED12445264GA SED12445265GA SED12445266GA SED12445268GA SED12445269GA SED12445298GA SED12445299GA SED12445309GA SEW12265533HA SEW13286489HA SEW14095097HA SEW14095105HA SEW14105496HA SEW14105497HA SEW14105502HA SEW14105503HA SEW14160623HA SEW14160626HA SEW14171213HA SEW14171313HA SEW14171314HA SEW14171315HA SEW14171317HA SEW14171319HA SEW14171320HA SEW14171321HA SKA14062508GA SKA14062511GA SKA14284377GA SKA14284378GA SKA14284382GA SKA14284385GA SKA14284388GA SKA14284393GA SKA14284394GA SKA14284395GA SKA14365356GA SKA14365375GA SKA14365378GA SKA14365380GA SKA14365382GA SKA14487159GA SKA14487160GA SKA14487161GA SKA14487162GA SKA14487163GA SKA14487165GA SKA14487166GA SKA14487168GA SKA14487170GA SKA14487171GA SKA14487172GA SKA14487173GA SKA14487174GA SKA14487175GA SKA14487176GA SKA14487178GA SKA14487180GA SKA14487182GA SKA14487185GA SKA14487218GA SKA15038500GA SKA15048558GA SMV15123913HA SMV15145547HA SMV15145548HA SMV15124159HA SEW12018091HA SKA13390428GA SKA13390435GA SKA13390440GA SKA13390468GA SKA13390474GA SKA13430502GA SKA13430503GA SKA13430504GA SKA13430505GA SMV15123911HA SED11067045GA SED12394559GA SKA14092755GA SMV15123912HA SED11229605GA SED11239640GA SED11239644GA SED11239645GA SED11239663GA SED11239664GA SED11239668GA SED11239669GA SED11239678GA SED11239679GA SED11239680GA SMV15123915HA
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.
  • Description du dispositif
    GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
  • Manufacturer
  • Modèle / numéro de série
    OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of: MD, NC, MT, NJ, UT and NY
  • Description du dispositif
    GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
  • Manufacturer
  • Modèle / numéro de série
    Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
  • Description du dispositif
    Gelseal Straight Diameter 8mm Length 15cm. || Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
  • Manufacturer
  • Modèle / numéro de série
    Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
  • Description du dispositif
    Gelseal Straight Diameter 8mm Length 30cm. || Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
  • Manufacturer
  • Modèle / numéro de série
    Model #: 882300; Serial #s: 1041, 1045, 5001, 1072R, 1075R, 1076R & G074.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Description du dispositif
    Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
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