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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance Big Bore

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 Class 2 Recall
Brilliance Big Bore
see related information
Date Posted February 03, 2012
Recall Status1 Terminated on February 22, 2013
Recall Number Z-0946-2012
Recall Event ID 60977
Premarket Notification
510(K) Number
K033357 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed Tomography X-Ray System intended to produce of x-ray transmission data taken at different angles and planes.
Code Information Model # 728243, Serial # 7006, 7009, 7060, 7068, 7081, 7095, 7122, 7127, 7133, 7150, 7154, 7185, 7233, 7245, 7278, 7285, 7298, 7337, 7395, 7400, 7450, 7465, 7468, 7506, 7518, 7520, 7521, 7523, 7524, 7528, 7545, 7547, 7560, 7568, 7569, 7573, 7578, 7581, 7584, 7591, 7593, 7597-7599, 7602, 7611, 7616, 7617, 7618, 7620, 7622-7635, 7637-7650, 7652, 7655-7659, 7661-7663, 7665-7667, 7671-7675, 7677-7682, 7684-7687, 7689-7691, 7693, 7695, 7696, 7698-7707, & 75000. Model # 728244, Serial # 7543, 7571, 7600, 7619, 7621, 7636, 7651, 7653, 7654, 7660, 7668-7670, 7676, 7683, 7688, 7694, 7697, 7708, & 7710.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
The Block and Multi Leaf Collimator (MLC) shape is not propagated to the beam that is modified by the Oppose operation. The contours can appear with the incorrect color in the Beam's Eye View Viewer, resulting in organs being incorrectly placed or incorrectly shaped.
FDA Determined
Cause 2
DESIGN: Software Design
Action On 12/13/2011, the firm sent Field Safety Notices, entitled URGENT - Medical Device Correction, to their customers. The letter identified the affected product, the problem, the hazard involved, and the actions to be taken by customers and the firm. Customers were to follow the instructions provided in order to address or avoid the issues. Philips will be installing a software update to address the identified issues free of charge. If customers need further information or support in regards to these issues, they are to contact their local Philips representative or local Philips Healthcare office. In North America and Canada, customers can contact the Customer Care Solutions Center at 1-800-722-9377.
Quantity in Commerce 142 Units
Distribution Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NM, NY, OH, OR, PA, PR, TN, TX, VA, & WA and countries of AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, DOMINICAN REPUBLIC, FRANCE, GABON, GERMANY, HUNGARY, ISRAEL, ITALY, JORDAN, LUXEMBOURG, MALI, MEXICO, NETHERLANDS, OMAN, SLOVAKIA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UKRAINE, UNITED ARAB EMIRATES, & UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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