Device Recall BRILLIANCE VOLUME

  • Model / Serial
    Serial Numbers: 100001-100063, 100065-100073 and 100075-100076.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA