Device Recall Brilliance Big Bore

  • Model / Serial
    Model # 728243, Serial # 7006, 7009, 7060, 7068, 7081, 7095, 7122, 7127, 7133, 7150, 7154, 7185, 7233, 7245, 7278, 7285, 7298, 7337, 7395, 7400, 7450, 7465, 7468, 7506, 7518, 7520, 7521, 7523, 7524, 7528, 7545, 7547, 7560, 7568, 7569, 7573, 7578, 7581, 7584, 7591, 7593, 7597-7599, 7602, 7611, 7616, 7617, 7618, 7620, 7622-7635, 7637-7650, 7652, 7655-7659, 7661-7663, 7665-7667, 7671-7675, 7677-7682, 7684-7687, 7689-7691, 7693, 7695, 7696, 7698-7707, & 75000.  Model # 728244, Serial # 7543, 7571, 7600, 7619, 7621, 7636, 7651, 7653, 7654, 7660, 7668-7670, 7676, 7683, 7688, 7694, 7697, 7708, & 7710.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NM, NY, OH, OR, PA, PR, TN, TX, VA, & WA and countries of AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, DOMINICAN REPUBLIC, FRANCE, GABON, GERMANY, HUNGARY, ISRAEL, ITALY, JORDAN, LUXEMBOURG, MALI, MEXICO, NETHERLANDS, OMAN, SLOVAKIA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UKRAINE, UNITED ARAB EMIRATES, & UNITED KINGDOM.
  • Product Description
    Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. || Computed Tomography X-Ray System intended to produce 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

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244  Serial #s: 76009 76030 76034 76007 76013 76014 76028 76047 76045 76073 76054 76077 76079 76069 76052 76083 76104 76082 76068 76100 76081 76092 76103 76097 76105 76043 76062 760007 76037 76090 76035 76004 76036 76072 76005 76015 760011 76033 76018 76019 76060 76056 76044 76094 76066 76038 76049 76046 76040 76085 76042 76003 76041 76058 76026 76059 76001 760015 76012 760001 76017 76048 76063 76050 76051 76039 76032 76029 76055 76065 76061 760006 76027 76053 760005 760003 76067 76057 760002 760016 76031 760019 760004 76006 76091 76070 760009 760008 760010 760012 760013 760014 760017 760018 76064 76088 76078 76107 76087 76080 76076 76075 76102 760021 76093 76095 760022 760020 76101 76074 76086 76084 76108 76071 76089 760023 760024 760025 760026
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 || Product Usage: || 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 analysts and display equipment, patient and equipment supports, components, and accessories.
  • Manufacturer
  • Model / Serial
    Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 || Product Usage: || 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 analysts and display equipment, patient and equipment supports, components, and accessories.
  • Manufacturer
  • Model / Serial
    Model #728243, Serial Numbers: 7006, 7154, and 7349.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.
  • Product Description
    Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. || Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
  • Model / Serial
    Model # 728243, Serial # 5005, 7006-7009, 7013-7051, 7053-7062, 7064-7120, 7122-7123, 7125-7158, 7160-7166, 7168-7171, 7173-7175, 7177-7179, 7181, 7183-7189, 7191-7199, 7201-7243, 7245-7251, 7253, 7255-7267, 7269, 7270, 7272-7295, 7297-7300, 7302-7304, 7306-7317, 7319-7374, 7376-7379, 7381, 7382, 7384, 7385, 7387-7389, 7392, 7393, 7395, 7397-7401, 7403-7406, 7409-7420, 74227426, 7428, 7429, 7431-7438, 7440-7451, 7454-7457, 7459, 7461-7473, 7475, 7477-7485, 7487-7509, 7511-7513, 7515, 7516-7528, 7530-7532, 7534-7537, 7539-7569, 7571, 7573, 7574, 7576-7582, 7584, 7585, 7588-7593, 7596-7603, 7605-7509, 7611-7613, 7615, 11683, 11698 & 75000.  Model # 728244, Serial # 7121, 7439, 7514, 7529, 7538, 7543, 7572, 7575, 7595, 7604, 7621, 7625, 7631, 7632, 7651 & 7654.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY. Product was also shipped to the following countries: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakstan, Kenya, Kuwait, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom & Venezuela.
  • Product Description
    Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed by: Philips Medical System, Cleveland, OH || Product Usage: The Computed Tomography X-Ray Systems are 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. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:  The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.  The detection, localization, and staging of tumors and diagnosing cancer patients.  Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
  • Manufacturer
  • Model / Serial
    Serial numbers: 7511, 7543, 7508, 7536, 7510, 7532, 7533, 7523, 7530, 7514,7502, 7551
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. (Nationwide) including the states of: CA, FL,, HI, IA, IN, KY, LA, MA,, MI, MO, MS. NM, NV, OH, PA, PA, SC, TN, TX, WA, and Puerto Rico
  • Product Description
    Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction || Product Usage: || The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are 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
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