Device Recall Brilliance CT System, Big Bore Configuration

  • Model / Serial
    Model 728243 Software version 2.2.1 and 2.2.2
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.
  • Product Description
    No packaging. The device is a computed tomography scanner. || Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Serial numbers 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125.
  • Product Classification
  • Distribution
    Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
  • Product Description
    Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
  • Manufacturer