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U.S. Department of Health and Human Services

Class 3 Device Recall Brilliance 16 Slice (Air)

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 Class 3 Device Recall Brilliance 16 Slice (Air)see related information
Date Initiated by FirmAugust 28, 2012
Date PostedSeptember 19, 2012
Recall Status1 Terminated 3 on December 24, 2013
Recall NumberZ-2404-2012
Recall Event ID 63006
510(K)NumberK012009 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductThe 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.
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
FEI Number 1525965
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information ContactKumudini J. Carter
440-483-7000
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.
FDA Determined
Cause 2		Software change control
ActionPhilips 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 Commerce93 units
DistributionWorldwide 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 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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