Class 2 Device Recall Brilliance 64:Computed Tomography Xray Systems,

• Date Initiated by Firm: February 05, 2016
• Create Date: April 08, 2016
• Recall Status: Terminated on July 02, 2018
• Recall Number: Z-1351-2016
• Recall Event ID: 73338
• 510(K)Number: K033326
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
• Code Information: Model No. 728231; S/N: 1, 2, 4001, 9056, 9074, 9099, 9134, 9251, 9515, 9529, 9538, 9549, 9554, 9573, 9574, 9618, 9625, 9638, 9646, 9653, 9656, 9659, 9667, 9670, 9686, 9689, 9690, 9703, 9738, 9740, 9755, 9782, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9898, 9901, 9909, 9910, 9917, 9920, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 10021, 10024, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10180, 10189, 10193, 10206, 10206, 10208, 10213, 10250, 10253, 10299, 10379, 10394, 10422, 10670, 10671, 10677, 10678, 10683, 10684, 10685, 10695, 10698, 10794, 10799, 10803, 29002, 29014, 29056, 29070, 29107, 29115, 90100, 90124, 90150, 90154, 91003, 95022, 95024, 95100, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95258, 95261, 95333, 95351, 95364, 95387, 95399, 95410, 95473, 95475, 95496, 95504, 95507, 95512, 95524, 95551, 95563, 95614, 95616, 95668, 95688, 95691, 95703, 95704, 95705, 95706, 95707, 95708, 95709, 95710, 95711, 95713, 95716, 95717, 95718, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95728, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95762, 95764, 95765, 95766, 95767, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95786, 95787, 95788, 95789, 95790, 95791, 95794, 95795, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95813, 95815, 95817, 95821, 95824, 95830, 95831, 95832, 95834, 95835, 95837, 95842, 95843, 95845, 95849, 95852, 95853, 95854, 95855, 95857, 95864, 95869, 95874, 95876, 95877, 95881, 95886, 95900, 95901, 95902, 95903, 95904, 95906, 95907, 95910, 95911, 95912, 95915, 95916, 95917, 95918, 95919, 95922, 95924, 95925, 95927, 95928, 95929, 95930, 95934, 95938, 95940, 95941, 95942, 95944, 95946, 95341A, 123002 & 123029.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Mrs. Holly Wright Lee; 440-483-2997
• Manufacturer Reason for Recall: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
• FDA Determined Cause: Software design
• Action: Philips Medical Systems sent a Customer Information dated February 5, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. To correct the issue Philips will release field change orders (FCO) 72800652 and 72800644 to install a software update on the affected systems. Customers with questions were instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts). For questions regarding this recall call 440-483-2997.
• Quantity in Commerce: 285 units
• Distribution: Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
• 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