Devices

Device Recall SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE , UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, ZAMBIA.
  • Descripción del producto
    This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. || Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.
  • Manufacturer
    GE Healthcare
  • 1 Event

Fabricante

GE Healthcare
  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall System, Nuclear Magnetic Resonance Imaging
  • Modelo / Serial
    4397, 5257, 4176, 1052, 4222, 4064, 5024, 4009, 4241, 5313, 1139, 5484, 4328, 5201,  5246, 5381, 4296, 4258, 5277, 4246, 1240, 5297, 5311, 5434, 5512, 506, 4207, 1072, 4089, 5373, 1014, 1078, 4025, 5551, 4131, 5455, 5328, 5379, 5261, 4416, 4206, 1191, 4088, 5195, 5334, 5451, 4383, 5250, 5309, 5342, 4183, 4272, 5268, 5009, 4047, 4254,  4261, 5307, 4102, 5199, 5558, 5315, 5266, 5303, 1061, 4307, 5390, 4267, 4386, 5282,  1113, 5123, 5501, 1062, 4339, 5383, 5478, 5507, 4162, 1015, 5162, 1081, 4170, 5477,  4322, 5515, 4069, 5081, 4201, 354, 5345, 4374, 4146, 1097, 5519, 5314
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    96 units distributed to 92 U.S. Customers
  • Descripción del producto
    Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips