Devices

Device Recall Brilliance CT Big Bore

  • Model / Serial
    System Code #, 728243, 728244, Serial #: 7022, 7118, 7151, 7298, 7343, 7360, 7361, 7362, 7363, 7364, 7365, 7366, 7367, 7368, 7369, 7370, 7371, 7372, 7373, 7374, 7375, 7376, 7377, 7378, 7379, 7380, 7381, 7382, 7383, 7384, 7385, 7386, 7387, 7388, 7389, 7390, 7391, 7392, 7393, 7394, 7395, 7396, 7397, 7398, 7399, 7400, 7401, 7402, 7403, 7404, 7405, 7406, 7407, 7408, 7409, 7410, 7411, 7412, 7413, 7414, 7415, 7416, 7417, 7418, 7419, 7420, 7421, 7422, 7423, 7424, 7425, 7426, 7427, 7428, 7429, 7430, 7431, 7432, 7433, 7434, 7435, 7436, 7437, 7438, 7439, 7440, 7441, 7442, 7443, 7444, 7445, 7446, 7447, 7448, 7449, 7450, 7451, 7452, 7453, 7454, 7455, 7456, 7457, 7458, 7459, 7461, 7462, 7463, 7464, 7465, 7466, 7467, 7468, 7469, 7470, 7471, 7472, 7473, 7474, 7475, 7476, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7486, 7487, 7488, 7489, 7490, 7491, 7492, 7493, 7494, 7495, 7496, 7497, 7498, 7499, 7500, 7501, 7502, 7503, 7503, 7504, 7505, 7506, 7507, 7508, 7509, 7510, 7511, 7512, 7513, 7514, 7515, 7516, 7517, 7518, 7519, 7520, 7521, 7522, 7523, 7524, 7525, 7526, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7534, 7535, 7536, 7537, 7538, 7539, 7540, 7541, 7542, 7543, 7544, 7545, 7546, 7547, 7548, 7549, 7550, 7551, 7552, 7553, 7554, 7555, 7556, 7557, 7558, 7559, 7560, 7561, 7562, 7563, 7564, 7565, 7566, 7567, 7568, 7569, 7570, 7571, 7572, 7573, 7574, 7575, 7576, 7577, 7578, 7578, 7579, 7580, 7581, 7582, 7583, 7584, 7585, 7586, 7587, 7588, 7589, 7590, 7591, 7592, 7593, 7594, 7595, 7596, 7597, 7598, 7599, 7600, 7601, 7602, 7603, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7611, 7612, 7613, 7614, 7615
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution incuding states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, and WI.
  • Product Description
    The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
  • 1 Event

Manufacturer

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

4 devices with a similar name

Learn more about the data here

Device Recall Brilliance CT Big Bore Oncology
  • Model / Serial
    System Code #, 728243, Serial #, 7039
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in China.
  • Product Description
    Brilliance CT Big Bore Oncology. || 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.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Brilliance CT Big Bore Radiology
  • Model / Serial
    Model #: 728244; Serial #s: 7486, 7510, 7514, 7525, 7529, 7533, 7538, 7543, 7544, 7546, 7557, 7570, 7571, 7572, 7575, 7576, 7583, 7586, 7587, 7594, 7595, 7600, 7604, 7607, 7610, 7614, 7619, 7621, 7625, 7631, 7632, 7636, 7651, 7653, 7654, 7660, 7668, 7669, 7670, 7676, 7683, 7686, 7688, 7692, 7694, 7697, 7708, 7710, 7711, 7712, 7713, 7714, 7717, 7719, 7721, 7722, 7723, 7732, 7733, 7734, 7738, 7742, 7746, 7747, 7756, 7760, 7764, 7766, 7767, 7771, 7772, 7773, 7778, 7780, 7781, 7789, 7790, 7798, 7804, 7809, 7813, 7819, 7825, 7826, 7830, 7839, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7943, 7952, 7957, 7958, 7959, 7964, 7967, 7979, 7981, 7986, 7988 & 7992.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • Product Description
    Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Brilliance CT Big Bore Oncology
  • Model / Serial
    921216
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
  • Product Description
    Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology
  • Model / Serial
    Model #: 728243; 7133, 7170, 7225, 7262, 7265, 7701, 7706, 7779, 7788, 7792, 7797, 7802, 7805, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7824, 7831, 7832, 7833, 7834 ,7835.  Model #728244; 7621, 7636, 7809 & 7844.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.
  • Product Description
    Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. || Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc