Class 2 Device Recall Philips Incisive CT

• Date Initiated by Firm: March 29, 2022
• Date Posted: December 18, 2023
• Recall Status: Completed
• Recall Number: Z-0576-2024
• Recall Event ID: 93509
• 510(K)Number: K180015 K212441
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
• Code Information: System Code: 728143 and 728144; UDI: (01)00884838105508(21)34035, (01)00884838105508(21)34029, (01)00884838105508(21)34030, (01)00884838105508(21)550007, (01)00884838105508(21)550009, (01)00884838105508(21)550068, (01)00884838105508(21)550012, (01)00884838105508(21)550044, (01)00884838105508(21)550049, (01)00884838105508(21)34021, (01)00884838105508(21)34076, (01)00884838105508(21)34094, (01)00884838105508(21)500519, (01)00884838105508(21)550024, (01)00884838105508(21)550048, (01)00884838105508(21)550062, (01)00884838105508(21)550003, (01)00884838105508(21)34063, (01)00884838105508(21)550027, (01)00884838105508(21)550029, (01)00884838105508(21)552006, (01)00884838105508(21)552007, (01)00884838105508(21)552009, (01)00884838105508(21)500502, (01)00884838105508(21)550020, (01)00884838085015(21)500367, (01)00884838085015(21)500379, (01)00884838085015(21)500521, (01)00884838085015(21)500138, (01)00884838085015(21)500308, (01)00884838105508(21)34074, (01)00884838105508(21)34102, (01)00884838105508(21)34053, (01)00884838105508(21)34092, (01)00884838105508(21)34008, (01)00884838105508(21)550026, (01)00884838105508(21)34028, (01)00884838105508(21)34039, (01)00884838105508(21)34048, (01)00884838105508(21)34069, (01)00884838085015(21)500110, (01)00884838085015(21)500111, (01)00884838105508(21)34041, (01)00884838105508(21)34036, (01)00884838105508(21)34065, (01)00884838105508(21)34061, (01)00884838085015(21)500433, (01)00884838105508(21)500517, (01)00884838105508(21)550060, (01)00884838105508(21)550061, (01)00884838085015(21)33023, (01)00884838105508(21)34001, (01)00884838085015(21)500443, (01)00884838105508(21)500452, (01)00884838105508(21)550035, (01)00884838105508(21)34004, (01)00884838105508(21)34005, (01)00884838105508(21)500503, (01)00884838105508(21)550042, (01)00884838105508(21)510043, (01)00884838105508(21)552002, (01)00884838105508(21)552005, (01)00884838105508(21)550054, (01)00884838105508(21)550056, (01)00884838105508(21)34081, (01)00884838105508(21)34080, (01)00884838085015(21)500441, (01)00884838085015(21)500338, (01)00884838105508(21)550013, (01)00884838105508(21)552014, (01)00884838105508(21)550041, (01)00884838105508(21)500504, (01)00884838105508(21)500514, (01)00884838105508(21)550006, (01)00884838105508(21)550067, (01)00884838105508(21)34070, (01)00884838085015(21)500030, (01)00884838085015(21)500133, (01)00884838085015(21)500104, (01)00884838105508(21)552013, (01)00884838085015(21)500439, (01)00884838085015(21)500119, (01)00884838085015(21)33018, (01)00884838085015(21)500324, (01)00884838085015(21)500113, (01)00884838105508(21)34034, (01)00884838085015(21)500330, (01)00884838085015(21)500416, (01)00884838085015(21)500321, (01)00884838085015(21)500350, (01)00884838105508(21)34046, (01)00884838085015(21)500163, (01)00884838105508(21)550000, (01)00884838105508(21)500499, (01)00884838085015(21)500146, (01)00884838105508(21)34108, (01)00884838105508(21)510039, (01)00884838105508(21)34037, (01)00884838105508(21)550004, (01)00884838085015(21)500005, (01)00884838085015(21)500019, (01)00884838085015(21)500408, (01)00884838105508(21)550010, (01)00884838105508(21)500515, (01)00884838105508(21)34011, (01)00884838105508(21)550036, (01)00884838105508(21)550008, (01)00884838085015(21)500323, (01)00884838105508(21)34020, (01)00884838105508(21)500530, (01)00884838105508(21)550040, (01)00884838085015(21)500360, (01)00884838085015(21)500470, (01)00884838105508(21)550059, (01)00884838105508(21)550034, (01)00884838105508(21)550025, (01)00884838105508(21)34003, (01)00884838105508(21)34002, (01)00884838105508(21)34075, (01)00884838085015(21)33038, (01)00884838085015(21)33046, (01)00884838085015(21)33012, (01)00884838085015(21)33045, (01)00884838105508(21)34085, (01)00884838105508(21)34006, (01)00884838105508(21)34051, (01)00884838105508(21)34105, (01)00884838085015(21)33041, (01)00884838105508(21)34047, (01)00884838085015(21)33002, (01)00884838105508(21)34033, (01)00884838105508(21)34019, (01)00884838085015(21)33042, (01)00884838105508(21)34083, (01)00884838085015(21)33025, (01)00884838105508(21)34043, (01)00884838085015(21)500396, (01)00884838105508(21)34084, (01)00884838105508(21)500516, (01)00884838105508(21)550065, (01)00884838105508(21)500501, (01)00884838105508(21)500506, (01)00884838085015(21)500475, (01)00884838085015(21)500027, (01)00884838105508(21)550043, (01)00884838085015(21)500401, (01)00884838105508(21)34023, (01)00884838085015(21)500025, (01)00884838105508(21)550021, (01)00884838105508(21)550014, (01)00884838085015(21)500417, (01)00884838085015(21)500322, (01)00884838105508(21)550053, (01)00884838105508(21)510046, (01)00884838105508(21)34107, (01)00884838105508(21)552011, (01)00884838105508(21)550005, (01)00884838105508(21)500536, (01)00884838105508(21)34079, (01)00884838105508(21)550066, (01)00884838105508(21)550033, (01)00884838105508(21)550019, (01)00884838105508(21)34067, (01)00884838105508(21)34031, (01)00884838085015(21)33034, (01)00884838105508(21)34032, (01)00884838105508(21)34072, (01)00884838105508(21)500531, (01)00884838085015(21)500411, (01)00884838105508(21)34082, (01)00884838085015(21)500476, (01)00884838105508(21)552000, (01)00884838105508(21)500505, (01)00884838085015(21)33019, (01)00884838105508(21)34071, (01)00884838105508(21)34106, (01)00884838085015(21)33020, (01)00884838085015(21)33021, (01)00884838085015(21)500473, (01)00884838105508(21)550051, (01)00884838085015(21)500358, (01)00884838085015(21)500270, (01)00884838085015(21)500319, (01)00884838085015(21)500215, (01)00884838085015(21)500313, (01)00884838085015(21)500271, (01)00884838085015(21)500071, (01)00884838105508(21)34009, (01)00884838105508(21)550046, (01)00884838085015(21)33029, (01)00884838105508(21)550032, (01)00884838085015(21)500316, (01)00884838105508(21)500454, (01)00884838085015(21)500462, (01)00884838085015(21)500430, (01)00884838085015(21)33010, 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(01)00884838105508(21)34097; Equipment Number: 97127344, 97127351, 97127346, 94808779, 94878276, 94808780, 94984190, 96161875, 96457814, 97598528, 99349025, 100353722, 94660960, 96506383, 96483951, 96454302, 95085734, 96621291, 95887893, 95984533, 97265085, 97320687, 97465137, 93909674, 95205133, 83541355, 83541960, 91681806, 83706469, 88315478, 99159836, 100665288, 98684958, 100221507, 96160762, 96000308, 96236084, 96621180, 96621365, 96619792, 83719826, 83720363, 98381573, 98167941, 97545869, 98561529, 92797435, 93514492, 97565570, 97582080, 93333252, 95510387, 93333254, 93575188, 96579399, 96556290, 96556291, 93682738, 96281213, 94354758, 93642574, 96787786, 96454720, 96454495, 99291318, 99291325, 92876933, 89450377, 93498323, 94044961, 95526392, 94080858, 93906704, 95019847, 96493777, 97616466, 82548602, 85711601, 85186365, 96468417, 92870027, 85469672, 92889235, 89504577, 84019318, 96451923, 89702922, 91926976, 89430835, 89915190, 96470333, 84799014, 94655384, 93496318, 85146962, 98791232, 94075767, 96436137, 94637834, 76844348, 80174381, 82017500, 94604476, 94751785, 96179883, 95808825, 94325563, 89297104, 96369805, 94305367, 95468396, 89228480, 92953643, 96364755, 95505799, 94906272, 96793435, 96470439, 99258404, 95033805, 92696776, 89506890, 95370037, 99367503, 96913762, 98530110, 100685830, 94933279, 98531980, 89496008, 97922129, 97642170, 95116211, 99348732, 93661754, 97375282, 89522790, 98347534, 94713152, 94696231, 93662882, 94691307, 93728239, 81731047, 95392934, 89777001, 97662063, 80150974, 94878278, 94860877, 91996730, 89473934, 96486169, 93665063, 100624570, 96135594, 94715511, 94362635, 99233532, 95006715, 95964493, 93641555, 99089303, 97848079, 94265606, 98150759, 99017606, 93664936, 91928837, 99290345, 93849561, 93643679, 93415171, 93098630, 99143439, 100620944, 92160634, 92868072, 93317501, 96282297, 89430151, 88120593, 89913439, 86687392, 89430831, 88121897, 81663416, 96236045, 96161527, 93552884, 96024573, 89430838, 93477700, 92823844, 92157218, 92693958, 91465483, 81492478, 98586858, 95441585, 95055302, 92865256, 95362963, 100278599, 92158516, 95720317, 94715154, 96016654, 82875264, 93387812, 89429360, 95152504, 87225967, 99233514, 76736410, 83310826, 100143393, 89430152, 89504402, 89472305, 89207448, 99159877, 93362293, 98772950, 93954868, 87226997, 96483025, 87227046, 96449129, 95113128, 98688573, 98484415, 85762575, 95156158, 100603388, 97433240, 98809044, 94590931, 93648090, 94811297, 95267211, 96467905, 93644014, 88470073, 92047046, 95845378, 93529093, 97433198, 96483049, 96001922, 95601637, 95600746, 96483103, 97714356, 96809322, 89316872, 97582219, 97550594, 84806473, 86890110, 89503429, 96828713, 100682852, 88208685, 95888654, 93666793, 92085956, 95512911, 100596674, 99290329, 100149814, 97069242, 95504632, 89842270, 98381570, 96395095, 88184662, 98971567, 94084434, 95676419, 97508811, 98484413, 86661414, 92083044, 93516684, 95986806, 93363033, 93518591, 93669386, 94316241, 98971554, 95131295, 97642190, 94500597, 100217205, 94814415, 94664159, 94814472, 93642949, 96215982, 95110174, 99089359, 96580906, 89997864, 96327577, 97014625, 96067612, 96377639, 96774006, 96927365, 97601484, 94929536, 96451802, 96997201, 100274967, 100521925, 98792250, 96492248, 98875082, 98594817, 98689355, 94533039, 98778986, 96132004, 98878526, 100237214, 98597398, 98779045, 100603730, 100598724; Serial No. 34035, 34029, 34030, 550007, 550009, 550068, 550012, 550044, 550049, 34021, 34076, 34094, 500519, 550024, 550048, 550062, 550003, 34063, 550027, 550029, 552006, 552007, 552009, 500502, 550020, 500367, 500379, 500521, 500138, 500308, 34074, 34102, 34053, 34092, 34008, 550026, 34028, 34039, 34048, 34069, 500110, 500111, 34041, 34036, 34065, 34061, 500433, 500517, 550060, 550061, 33023, 34001, 500443, 500452, 550035, 34004, 34005, 500503, 550042, 510043, 552002, 552005, 550054, 550056, 34081, 34080, 500441, 500338, 550013, 552014, 550041, 500504, 500514, 550006, 550067, 34070, 500030, 500133, 500104, 552013, 500439, 500119, 33018, 500324, 500113, 34034, 500330, 500416, 500321, 500350, 34046, 500163, 550000, 500499, 500146, 34108, 510039, 34037, 550004, 500005, 500019, 500408, 550010, 500515, 34011, 550036, 550008, 500323, 34020, 500530, 550040, 500360, 500470, 550059, 550034, 550025, 34003, 34002, 34075, 33038, 33046, 33012, 33045, 34085, 34006, 34051, 34105, 33041, 34047, 33002, 34033, 34019, 33042, 34083, 33025, 34043, 500396, 34084, 500516, 550065, 500501, 500506, 500475, 500027, 550043, 500401, 34023, 500025, 550021, 550014, 500417, 500322, 550053, 510046, 34107, 552011, 550005, 500536, 34079, 550066, 550033, 550019, 34067, 34031, 33034, 34032, 34072, 500531, 500411, 34082, 500476, 552000, 500505, 33019, 34071, 34106, 33020, 33021, 500473, 550051, 500358, 500270, 500319, 500215, 500313, 500271, 500071, 34009, 550046, 33029, 550032, 500316, 500454, 500462, 500430, 33010, 510013, 500037, 34050, 550016, 33031, 500477, 33037, 34089, 500421, 550050, 550001, 552008, 500082, 500509, 500356, 550047, 500243, 34078, 500007, 500060, 34088, 500343, 500425, 500365, 500328, 34073, 500453, 34057, 500511, 500236, 34016, 500246, 550069, 552003, 34054, 34040, 500192, 550022, 34104, 550058, 34062, 500512, 500507, 500537, 500553, 34027, 510040, 500298, 500387, 33040, 33030, 550055, 500568, 550011, 510045, 510047, 550028, 552012, 550038, 500320, 550064, 34025, 500124, 500398, 500374, 550070, 34101, 500461, 552001, 550002, 500431, 550018, 34103, 34077, 34090, 34045, 550023, 500383, 34038, 34022, 500283, 34066, 500494, 552004, 550057, 34042, 500259, 500418, 500538, 550063, 500508, 500518, 500500, 500513, 34064, 33033, 34018, 34010, 34086, 34014, 500529, 34013, 500520, 550017, 550030, 34068, 550037, 500381, 550052, 34007, 550039, 34015, 550045, 552010, 34026, 500533, 34044, 34087, 34093, 34095, 34058, 34024, 34059, 34049, 34056, 550015, 34055, 550031, 540020, 34091, 34052, 34060, 34100, 34097.
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Care Solutions; 800-722-9377
• Manufacturer Reason for Recall: Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
• FDA Determined Cause: Software design
• Action: Customers were sent IMPORTANT PRODUCT NOTICE letters dated 03/29/2022 via USPS. Consignees were asked to identify any affected devices at their facility utilizing the provided instructions, refer to the provided Appendix A for specific details regarding the three issue descriptions and work arounds provided to customers, place the notice with the documentation of the system until all issues have been resolved, and circulate this notice to all users of this device so that they are aware. A Philips Field Service Engineer will contact consignees to schedule a software upgrade. Customers with any questions can contact their local Philips representative and reference FCO72800772 or contact the Customer Care Solutions Center at 1-800-722-9377.
• Quantity in Commerce: 330 units
• Distribution: Domestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ, NM, NY, OH, OK, PA, RI, TN, TX; Foreign: Albania, Argentina, Australia, Austria, Bolivia, Bosnia-Herzegovina , Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Kosovo, Lao People's Democratic Republic, Latvia, Lebanon, Moldova, Morocco, Netherlands, Palestine, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russian Federation, Saint Lucia, Saint Pierre and Miquelon, Sint Maarten , South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, 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.

• 510(K) Database: 510(K)s with Product Code = JAK