Device Recall GE PET Discovery 610, PET Discovery 710

  • Modèle / numéro de série
    MfgLotorSerial# 00000428413CN9 00000429077CN1 00000429247CN0 00000430152CN9 00000430656CN9 00000430999CN3 00000431369CN8 00000429701CN6 00000430064CN6 00000431187CN4 00000429354CN4 00000431447CN2 00000293950HM2 00000429821CN2 00000429946CN7 00000430001CN8 00000293950HM2 00000430632CN0 Shipped Shipped Shipped 00000429572CN1 00000428755CN3 00000428755CN3 00000428868CN4 00000293949HM4 00000428536CN7 00000429820CN4
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.
  • Description du dispositif
    GE PET Discovery 610, PET Discovery 710. || Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA