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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64 and Ingenuity CT Computed Tomography XRay Systems

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 Class 2 Device Recall Brilliance 64 and Ingenuity CT Computed Tomography XRay Systemssee related information
Date Initiated by FirmMarch 12, 2012
Date PostedApril 02, 2012
Recall Status1 Terminated 3 on June 18, 2013
Recall NumberZ-1361-2012
Recall Event ID 61445
510(K)NumberK033326 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductBrilliance 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information ContactMr. Joseph Vinhais
440-483-7000
Manufacturer Reason
for Recall		Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having Software Version 3.5.1. When the user plans a scan with tilt applied, the scan increment changes from the user defined values (noncontiguous) to a contiguous scan.
FDA Determined
Cause 2		Software design
Action.
Quantity in Commerce440 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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