Devices

Device Recall HiSpeed X/i Computed Tomography

  • Modelo / Serial
    Console Serial Numbers: 074639HM6, 659297YM6, 695155YM2, 730392YM8, 777756YM8, 789223YM5, 818161YM2, 836965YM4, 836971YM2, 864568YM 1, 869641 YM 1, 530941YM4, 594144YM8, 659292YM7, 678189YM2, 65931 1YM5, 696890YM3, 530873YM9, 659208YM3, 730349YM8, 544504YM4, 766560YM7, 766630YM8, 856398YM3, 474793YM7, 530946YM3, 874664YM6, 813279YM7, 839995YM8, 854095YM7, 869512YM4, 766587YMO, 887561YM9, 840000YM4, 813261 YM5, 717723YM1, 717727YM2, 877979YM5, 808479YMO, 812782YM1, 659200YMO, 766610OYMO, 877971YM2, 730393YM6, and 865531YM8.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, and WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia.
  • Descripción del producto
    HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. || The expected usage of this product is to generate head and whole body CT images of human subjects.
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

Fabricante

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