Class 2 Device Recall Brilliance Big Bore

• Date Initiated by Firm: December 13, 2011
• Date Posted: February 03, 2012
• Recall Status: Terminated on February 22, 2013
• Recall Number: Z-0946-2012
• Recall Event ID: 60977
• 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 OH 44143-2131
• For Additional Information Contact: 440-483-7000
• 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: 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 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 = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.