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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64 CT System

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 Class 2 Device Recall Brilliance 64 CT Systemsee related information
Date Initiated by FirmMarch 03, 2011
Date PostedDecember 10, 2015
Recall Status1 Terminated 3 on December 15, 2015
Recall NumberZ-0409-2016
Recall Event ID 69055
510(K)NumberK033326 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductBrilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. 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.
Code Information Serial numbers: 4001, 4020, 4021, 9030, 9033, 9040, 9041, 9048, 9049, 9062, 9074, 9083, 9093, 9105, 9106, 9107, 9108, 9112, 9123, 9126, 9127, 9131, 9135, 9137, 9139, 9140, 9142, 9148, 9151, 9159, 9160, 9162, 9163, 9166, 9171, 9173, 9175, 9177, 9180, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9214, 9215, 9216, 9217, 9218, 9235, 9501, 9502, 9503, 9504, 9505, 9506, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542,9543, 9544, 9545, 9546, 9547, 9548, 9549, 9550, 9551, 9552, 9553, 9554, 9555, 9556, 9557, 9558, 9559, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9595, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9610, 9611, 9612, 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Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactMrs. Holly Wright Lee
440-483-5777
Manufacturer Reason
for Recall
Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
FDA Determined
Cause 2
Software design
ActionOn March 3, 2011, the firm sent Field Service Notices to their customers.
Quantity in Commerce1,765 units
DistributionWorldwide Distribution. US nationwide, including Puerto Rico, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam & Yemen.
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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