Devices

MRI Systems

  • Modèle / numéro de série
    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx. Signa HDxt, Signa HDi, Signa Vibrant, GE 1.5T Signa HDe, Optima MR360, Brivo MR355. All SR Viewer versions 2.4.1 and 2.6.13 on the MR console of the listed products identified above are affected.
  • Description du dispositif
    The involved systems are whole body magnetic resonance scanners designed to support high resolution and high signal-to-noise ratio images in short exam times. They are indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.
  • Manufacturer
    GE Healthcare
  • 1 Event

Fabricant

GE Healthcare

45 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

GE Healthcare MRI Systems
  • Modèle / numéro de série
    Model: All MRI models, Affected: All serial numbers
  • Manufacturer
    GE Medical Systems LLC
GE Signa HDxt MRI Systems
  • Modèle / numéro de série
    Model: Signa Excite HDxt, Affected: All serial numbers
  • Manufacturer
    GE Medical Systems LLC
Philips Intera and Achieva MRi Systems
Pipes without a safety pressure valve connected to Blackmax, Micromax, Xmax and iMRI systems
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    Anspach
Device Recall Multiple GE MRI systems
  • Modèle / numéro de série
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including PR, GU and DC., and to the countries of: ALBANIA. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY. GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAHHSTAN,KENYA,REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMA N,PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SIERRA LEONE, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UGANDA , UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM and ZAMBIA.
  • Description du dispositif
    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE || MRI Systems
  • Manufacturer
    GE Healthcare
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