Device Recall BRILLIANCE VOLUME

  • Modèle / numéro de série
    Serial Numbers: 100001-100063, 100065-100073 and 100075-100076.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US including DC (states of CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, and MD), Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand.
  • Description du dispositif
    Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. || The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA