Device Recall Brilliance 16 Computed Tomography Xray systems

  • Model / Serial
    Model #: 728246; Serial #s: 3010, 3017, 3031, 3040, 3043, 3070, 3072, 3085, 3090, 3117, 3123, 3149, 3179, 3216, 3247, 3293, 3314, 3324, 3411, 3465, 3490, 5006, 5009, 5012, 5018, 5020, 5024, 5026, 5028, 5030, 5031, 5035, 5044, 5045, 5048, 5052, 5053, 5054, 5055, 5058, 5059, 5060, 5064, 5069, 5070, 5075, 5077, 5081, 5086, 5088, 5091, 5093, 5097, 5099, 5101, 5103, 5107, 5108, 5110, 5111, 5113, 5115, 5116, 5118, 5120, 5123, 5126, 5127, 5128, 5131, 5135, 5138, 5140, 5147, 5155, 5160, 5161, 5163, 5166, 5181, 5184, 5186, 5188, 5190, 5191, 5192, 5193, 5195, 5197, 5208, 5209, 5216, 5219, 5224, 5231, 5235, 5236, 5237, 5270, 5272, 5279, 5282, 5285, 5287, 5288, 5294, 5295, 5315, 5316, 5347, 5348, 5350, 5354, 5357, 5360, 5368, 5394, 5405, 5412, 5433, 5434, 5443, 5453, 5457, 5474, 5480, 5487, 5501, 5502, 5505, 5516, 5519, 5523, 5526, 5554, 5572, 5573, 5576, 5609, 5615, 5633, 5647, 5653, 5674, 5683, 5703, 5723, 5758, 5762, 5764, 5771, 5811, 5897, 5929, 5937, 5956, 5974, 5995, 6021, 6022, 6031, 6033, 6048, 6053, 6072, 6154, 6220, 6229, 6243, 6280, 6283, 6298, 6299, 6309, 6321, 6360, 6375, 6405, 6426, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6549, 6555, 6559, 30011, 30049, 30110, 32287, 32366, 50011, 50053, 50087, 50180, 50181, 5238A.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
  • Product Description
    Brilliance 16 Computed Tomography X-ray systems is 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 Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA