Devices

Brilliance Big Bore CT XRay System

  • Model / Serial
    Model Number: 728243, Serial Numbers: 7298, and 7060.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Texas and the countries of Italy, India and China.
  • Product Description
    Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 software. || The Brilliance Big Bore and Brilliance 64 are Computed Tomography X-Ray Systems intended thio product 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
    Philips Medical Systems (Cleveland) Inc
  • 1 Event

Manufacturer

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

One device with a similar name

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Device Recall Brilliance Big Bore CT XRay System
  • Model / Serial
    The following Serial Numbers of the Brilliance CT Big Bore system are subject to recall/software correction: 7006, 7060, 7154, 7298, and 7349.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.
  • Product Description
    Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030. || Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc