Device Recall Brilliance 64 and Ingenuity CT Computed Tomography XRay Systems

  • Model / Serial
    System Code #728231, 4003, 4021, 9033, 9037, 9041, 9045, 9048, 9062, 9064, 9070, 9075, 9080, 9108, 9120, 9142, 9151, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9214-9218, 9462, 9508, 9531, 9534, 9535, 9544, 9554, 9561, 9584, 9603, 9606, 9608, 9613, 9627, 9630, 9657, 9668, 9671, 9672, 9695, 9706, 9708, 9719, 9728, 9734, 9735, 9741, 9745, 9756, 9789, 9819, 9832, 9838, 9839, 9840, 9859, 9874, 9875, 9891, 9898, 9904, 9918, 9926, 9952, 9964, 9965, 9968, 9975, 9997, 9999, 10000, 10008, 10015, 10041, 10052, 10054, 10092, 10095, 10100, 10103, 10114, 10125, 10145, 10151, 10152, 10154, 10170-10172, 10192, 10196, 10198, 10221, 10222, 10251, 10256, 10273, 10286, 10294, 10307, 10312, 10336, 10337, 10350, 10352, 10362, 10363, 10372, 10376, 10380, 10386, 10393, 10412, 10425, 10426, 10428, 10438, 10445, 10446, 10452, 10459, 10461, 10468, 10470, 10471, 10473, 10482, 10486, 10489, 10491, 10493, 10497, 10503, 10505, 10511-105531, 10533-10555, 10557-10566, 10568-10575, 10577-10604, 10606, 10608-10620, 10622-10624, 10628-10640, 29037, 29049, 29057, 64040, 90036, 90054, 90058, 90063, 90080, 90100, 90102, 90106, 90117, 90135, 90169, 90182, 91003, 95015, 95055, 95065, 95074, 95077, 95101, 95108, 95130, 95133, 95138, 95140, 95157, 95168, 95174, 95178, 95184, 95185, 95191, 95207, 95243, 95295, 95315, 95324, 95327, 95350, 95357, 95358, 95362, 95389, 95403, 95414, 95425, 95429, 95443, 95455, 95504, 95516, 95529, 95534, 95568, 95570, 95572, 95573, 95575, 95602, 95605, 95609, 95613, 95624, 95630, 95638, 95652, 95659, 95664, 95665, 95677, 95684, 95687, 95697, 95700-95728 & 300074.  System Code #: 728326, Serial #: 9511, 300003-300005, 300010-300022, 300024, 300025, 300027-300066 & 300068-300073.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, AR, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MT, ND, NE, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA and WV, and the countries of Australia, Bahamas, Bangladesh, Belgium, Bolivia, Brazil, Chile, China, Colombia, Croatia, Denmark, Finland, France, Georgia, Germany, Great Britain, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Laos, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Russia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam.
  • Product Description
    Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model# 728231, Ingenuity CT Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. || The Brilliance 64 and Ingenuity CT 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

Manufacturer

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