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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 6, 10, 16, 40, 64 and CT Big Bore

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 Class 2 Device Recall Brilliance 6, 10, 16, 40, 64 and CT Big Boresee related information
Date Initiated by FirmAugust 03, 2012
Date PostedAugust 22, 2012
Recall Status1 Terminated 3 on July 23, 2015
Recall NumberZ-2245-2012
Recall Event ID 62790
510(K)NumberK012009 K033326 K033357 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductThe Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories
Code Information System Code # 728243, Serial #s: 7392, 7394, 7399, 7405, 7406, 7429, 7433, 7440, 7457, 7465, 7469, 7479, 7481, 7487, 7488, 7491, 7502, 7506, 7507, 7517, 7518, 7520, 7521, 7532, 7539, 7545, 7547, and 7556.  System Code # 728244, Serial #s: 7190, 7195, 7318, 7383, 7427, 7430, 7510, and 7533.  System Code #728256, Serial #s: 3163, 3500, 3500, 5623, 5655, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5813, 5836, 5855, 5862, 5868, 5877, 5897, 5911, 5911, 5916, 5935, 5969, and 5997.  System Code #728251, Serial #: 4051.  System Code # 728246, Serial #s: 5547, 5585, 5791, 5803, 5876, 5974.  System Code # 728235, Serial #s: 9233, 9234, 9261, 95022.  System Code # 728231, Serial #s: 9867, 9925, 9931, 9980, 9996, 10009, 10011, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10133, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10153, 10166, 10170, 10172, 10198, 10203, 95109, 95348, 95563.  
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		The patient support may move in an unintended manner if the foot switch cover becomes damaged and impinges on the foot switch.
FDA Determined
Cause 2		Device Design
ActionPhilips Medical Systems (Cleveland), Inc. sent an Urgent - Medical Device Correction letter dated August 1, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taked. The letter contained important information for the continued safe and proper use of your equipment. The letter stated that, a Field Service Engineer will visit each affected site to install the hardware upgrade. For further information or support concerning this issue contact your local Philips representative or local Philips Health office. For North America and Canada contact Customer Care Solution Center (1-800-722-9377), option 5: Enter Site ID or Follow the prompts).
Quantity in Commerce126 units
DistributionWorldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, DC, FL, GA, KY, MD, MI, MN, MS, ND, NM, NY, OH, OK, SC, TN, TX, VT, WA, and WI and the countries of: Austria, China, Denmark, France, Germany, Iceland, Japan, Netherlands, South Africa, Sweden, Switzerland, United Kingdom. There were two government consignees. There were no Canadian consignees.
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
510(K)s with Product Code = JAK
510(K)s with Product Code = JAK
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