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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 Recall
Brilliance 64 and Ingenuity CT Computed Tomography XRay Systems
see related information
Date Posted April 02, 2012
Recall Status1 Terminated on June 18, 2013
Recall Number Z-1361-2012
Recall Event ID 61445
Premarket Notification
510(K) Number
K033326 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product 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.
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, Ohio 44143-2131
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. 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
DESIGN: Software Design
Action .
Quantity in Commerce 440 units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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