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
  • 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
  • 1 Event

Manufacturer

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