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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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 Class 2 Recall
Philips
see related information
Date Posted October 17, 2013
Recall Status1 Terminated on May 14, 2014
Recall Number Z-0013-2014
Recall Event ID 66296
Premarket Notification
510(K) Numbers
K012009  K033357 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body 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 #: 7040, 7083, 7087, 7123, 7124, 7133, 7170, 7178, 7204, 7231, 7273, 7328, 7365, 7370, 7395, 7434, 7467, 7596, 7612, 7775, 7794, 7795, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7854, 7855, 7856, 7857, 7858, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7871, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7912, 7914, 7915, 7916, 7918, 7920, 7921, 7923, 7924, 7926, 7927, 7928, 7930, 7931, 7932, 7934, 7935, 7936, 7937, 7938, 7940, 7941, 7942, 7943, 7944 and 7945. System Code #728244, Serial #: 7121, 7271, 7764, 7844, 7845, 7853, 7859, 7862, 7869, 7870, 7874, 7878, 7879, 7880, 7882, 7887, 7888, 7894, 7897, 7899, 7903, 7906, 7913, 7917, 7919 and 7922. System Code #728246, Serial #: 3079, 3090, 3127, 3410, 3478, 3500, 3679, 3721, 5067, 5072, 5073, 5143, 5317, 5439, 5663, 5728, 5741, 5928, 5971, 6028, 6052, 6061, 6067, 6090, 6107, 6133, 6147, 6153, 6156, 6162, 6231, 6491, 6556, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6676, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6689, 6695, 6696, 6697, 6707, 6710, 6711, 6714, 6721, 30075, 40013, 50026, 50043, 50177, 50181, 50182, 50189, 50195, 50198, 50200 and 60009.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips sent an "Urgent - Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem If you need any further information or Support concerning this issue, please contact your 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). This notice has been reported to the appropriate Regulatory Agency. Philips apologizes for any inconveniences caused by this problem.
Quantity in Commerce 258
Distribution Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR,TN, TX, UT, VA, VT and WV., and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Denmark, Egypt, France, Germany, Honduras, India, Indonesia, Italy, Kazakhstan, Latvia, Lebanon, Libyan Arab Jamahiriya, Mexico, Netherlands, Norway, Palestine, Philippines, Poland, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam.
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 = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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