Ingenuity CT

Model #728326, Serial Numbers: 300003, 300004, and 300005.

Radiology Devices

2

No

Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. 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.

The following Serial Numbers of this device are subject to recall: Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) in the states of: LA, NY, OH, WV and the foreign countries of: Australia, Germany, Korea, India, Malaysiaa and New Zealand.

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. || Product Usage: || The Ingenuity CT 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 different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

The following Serial Numbers are subject to recall/software correction: 300003, 300004, 300005, and 300010.

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: IN and OR; and countries of: Australia and Germany.

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. || Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-a¿sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

System Code # 728231, Serial # 91003, 95130, 95157, 95504 & 300030; System Code # 728326, Serial # 300010 & 300018.

Radiology Devices

2

No

Worldwide Distribution - USA including OH and the following countries: Australia, China, Belgium, Israel & Sweden.

Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH

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.

Radiology Devices

2

No

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.

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.