Device Recall Brilliance iCT and iCT SP

  • Modèle / numéro de série
    Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, VT, WA and WV and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hungary, Iceland, India, Indonesia, Iraq, ISRAEL, Italy, Japan, Jordan, Korea, Lebanon, Mexico, Netherlands, New Zealand , Norway, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates and Uzbekistan.
  • Description du dispositif
    The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices 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

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  • Modèle / numéro de série
    Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506  Brilliance iCT SP: 728311, Serial #'s: 200047, 200121
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.
  • Description du dispositif
    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH || The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
  • Manufacturer