—#204602

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K180015, K212441
Affected lot / code info: 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)552003, (01)00884838105508(21)34054, (01)00884838105508(21)34040, (01)00884838085015(21)500192, (01)00884838105508(21)550022, (01)00884838105508(21)34104, (01)00884838105508(21)550058, (01)00884838105508(21)34062, (01)00884838105508(21)500512, (01)00884838105508(21)500507, (01)00884838105508(21)500537, (01)00884838085015(21)500553, (01)00884838105508(21)34027, (01)00884838105508(21)510040, (01)00884838085015(21)500298, (01)00884838085015(21)500387, (01)00884838085015(21)33040, (01)00884838085015(21)33030, (01)00884838105508(21)550055, (01)00884838085015(21)500568, (01)00884838105508(21)550011, (01)00884838105508(21)510045, (01)00884838105508(21)510047, (01)00884838105508(21)550028, (01)00884838105508(21)552012, (01)00884838105508(21)550038, (01)00884838085015(21)500320, (01)00884838105508(21)550064, (01)00884838105508(21)34025, (01)00884838085015(21)500124, (01)00884838085015(21)500398, (01)00884838085015(21)500374, (01)00884838105508(21)550070, 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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, 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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.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-03-29
Posted by FDA: 2023-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.