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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT 6, Brilliance CT 16, Brilliance CT 40, & Brilliance CT 64

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  Class 2 Device Recall Brilliance CT 6, Brilliance CT 16, Brilliance CT 40, & Brilliance CT 64 see related information
Date Initiated by Firm July 05, 2013
Date Posted September 16, 2013
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-2210-2013
Recall Event ID 65691
510(K)Number K012009  K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143.

Intended to produce cross-sectional images of the body by computer reconstruction.
Code Information Model #, 728231, Serial #: 4021, 9535, 9544, 9587, 9627, 9701, 9707, 9713, 9759, 9875, 9887, 9917, 9925, 9931, 9980, 9996, 10009, 10011, 10012, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10152, 10153, 10154, 10162, 10165, 10166, 10170, 10171, 10172, 10173, 10188, 10189, 10191, 10196, 10198, 10203, 10214, 10222, 10227, 10228, 10229, 10230, 10235, 10238, 10242, 10243, 10247, 10259, 10260, 10261, 10263, 10268, 10273, 10274, 10278, 10288, 10291, 10293, 10294, 10297, 10298, 10301, 10302, 10307, 10312, 10313, 10316, 10317, 10318, 10319, 10320, 10327, 10336, 10337, 10341, 10347, 10349, 10350, 10351, 10352, 10353, 10362, 10365, 10376, 10380, 10384, 10387, 10393, 10400, 10411, 10412, 10414, 10431, 10438, 10439, 10445, 10446, 10452, 10453, 10459, 10461, 10468, 10470, 10471, 10476, 10482, 10486, 10490, 10491, 10503, 10511, 10513, 10519, 10535, 10536, 10540, 10544, 10546, 10551, 10554, 10561, 10563, 10568, 10569, 10574, 10582, 10600, 10617, 10628, 10631, 10635, 10646, 10647, 10651, 10655, 10659, 10673, 10684, 10686, 10698, 10714, 10733, 10734, 29002, 29014, 29016, 29027, 90054, 90099, 95022, 95046, 95073, 95103, 95107, 95109, 95114, 95132, 95133, 95181, 95209, 95268, 95295, 95305, 95371, 95453, 95473, 95563, 95660, 95704, 95706, 95707, 95712, 95715, 95721, 95727, 95729, 95769, 95778, 90199 & 95162.  Model #, 728235, Serial #: 9034, 9190, 9233, 9234, 9261, 29049, 29057, 29064 & 29149.  Model #, 728246, Serial #: 3150, 3163, 4051, 5547, 5585, 5623, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5791, 5803, 5813, 5836, 5855, 5862, 5868, 5876, 5877, 5897, 5911, 5916, 5935, 5969, 5971, 5974, 5997, 6001, 6006, 6008, 6028, 6087, 6102, 6117, 6120, 6121, 6126, 6170, 6195, 6200, 6202, 6203, 6238, 6243, 6281, 6287, 6306, 6318, 6324, 6346, 6352, 6387, 6402, 6405, 6444, 6484, 6491, 6494, 6495, 6496, 6503, 6517, 6519, 6523, 6556, 6559, 6609, 6610, 6611, 6612, 6623, 6624, 6640, 6642, 50115, 50147, 50166, 50180, 50189, 50193, 50195, 50197, 50198, 50204 & 50043.  Model #, 728256, Serial #: 3490, 3500, 3679 & 3693.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7600
Manufacturer Reason
for Recall		 The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.
FDA Determined
Cause 2		 Component design/selection
Action Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Care Center at 1-800-722-9377, option 5 for information concerning this issue.
Quantity in Commerce M/N: 728256, 4 units; M/N: 728246, 89 units; M/N: 728235, 9 units & M/N: 728231, 207 units
Distribution Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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