| Class 2 Device Recall Brilliance 64 CT System | |
Date Initiated by Firm | March 03, 2011 |
Date Posted | December 10, 2015 |
Recall Status1 |
Terminated 3 on December 15, 2015 |
Recall Number | Z-0409-2016 |
Recall Event ID |
69055 |
510(K)Number | K033326 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Brilliance 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, 9613, 9614, 9615, 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Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Mrs. 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 |
Action | On March 3, 2011, the firm sent Field Service Notices to their customers. |
Quantity in Commerce | 1,765 units |
Distribution | Worldwide 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 Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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