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Class 3 Device Recall Brilliance 16 Slice (Air) |
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Date Initiated by Firm |
August 28, 2012 |
Date Posted |
September 19, 2012 |
Recall Status1 |
Terminated 3 on December 24, 2013 |
Recall Number |
Z-2404-2012 |
Recall Event ID |
63006 |
510(K)Number |
K012009
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
The Brilliance CT 16 System
Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
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Code Information |
System Code #, 728246, Serial #, 6462, 6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448, 6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505, 6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490, 6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463, 6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464, 6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507, 6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland OH 44143-2131
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For Additional Information Contact |
Kumudini J. Carter 440-483-7000
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Manufacturer Reason for Recall |
Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
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FDA Determined Cause 2 |
Software change control |
Action |
Philips sent an Urgent - Medical Device Correction letter dated August 24, 2012 via certified mail to all US consignees. Philips Key Market representatives distributed the letter internationally. The letter identified the affected product, problem and actions to be taken by customer/user. Philips is implementing a software update to correct the issue free of charge. A Philips representative will contact affect sites to schedule the software installation. For further information or support contact your Philips representative or local Philips Healthcare office. |
Quantity in Commerce |
93 units |
Distribution |
Worldwide Distribution - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, United Arab Emirates, and India. |
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 and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
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