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.
- Company
- Philips North America Llc
- Recall Initiated
- March 29, 2022
- Posted
- December 18, 2023
- Recall Number
- Z-0576-2024
- Quantity
- 330 units
- Firm Location
- Cambridge, MA
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.
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.
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, (01)00884838085015(21)510013, (01)00884838085015(21)500037, (01)00884838105508(21)34050, (01)00884838105508(21)550016, (01)00884838085015(21)33031, (01)00884838085015(21)500477, (01)00884838085015(21)33037, (01)00884838105508(21)34089, (01)00884838085015(21)500421, (01)00884838105508(21)550050, (01)00884838105508(21)550001, (01)00884838105508(21)552008, (01)00884838085015(21)500082, (01)00884838105508(21)500509, (01)00884838085015(21)500356, (01)00884838105508(21)550047, (01)00884838085015(21)500243, (01)00884838105508(21)34078, (01)00884838085015(21)500007, (01)00884838085015(21)500060, (01)00884838105508(21)34088, (01)00884838085015(21)500343, (01)00884838085015(21)500425, (01)00884838085015(21)500365, (01)00884838085015(21)500328, (01)00884838105508(21)34073, (01)00884838105508(21)500453, (01)00884838105508(21)34057, (01)00884838105508(21)500511, (01)00884838085015(21)500236, (01)00884838105508(21)34016, (01)00884838085015(21)500246, (01)00884838105508(21)550069, (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, (01)00884838105508(21)34101, (01)00884838085015(21)500461, (01)00884838105508(21)552001, (01)00884838105508(21)550002, (01)00884838085015(21)500431, (01)00884838105508(21)550018, (01)00884838105508(21)34103, (01)00884838105508(21)34077, (01)00884838105508(21)34090, (01)00884838105508(21)34045, (01)00884838105508(21)550023, (01)00884838085015(21)500383, (01)00884838105508(21)34038, (01)00884838105508(21)34022, (01)00884838085015(21)500283, (01)00884838105508(21)34066, (01)00884838085015(21)500494, (01)00884838105508(21)552004, (01)00884838105508(21)550057, (01)00884838105508(21)34042, (01)00884838085015(21)500259, (01)00884838085015(21)500418, (01)00884838105508(21)500538, (01)00884838105508(21)550063, (01)00884838105508(21)500508, (01)00884838105508(21)500518, (01)00884838105508(21)500500, (01)00884838085015(21)500513, (01)00884838105508(21)34064, (01)00884838085015(21)33033, (01)00884838105508(21)34018, (01)00884838105508(21)34010, (01)00884838105508(21)34086, (01)00884838105508(21)34014, (01)00884838105508(21)500529, (01)00884838105508(21)34013, (01)00884838105508(21)500520, (01)00884838105508(21)550017, (01)00884838105508(21)550030, (01)00884838105508(21)34068, (01)00884838105508(21)550037, (01)00884838085015(21)500381, (01)00884838105508(21)550052, (01)00884838105508(21)34007, (01)00884838105508(21)550039, (01)00884838105508(21)34015, (01)00884838105508(21)550045, (01)00884838105508(21)552010, (01)00884838105508(21)34026, (01)00884838085015(21)500533, (01)00884838105508(21)34044, (01)00884838105508(21)34087, (01)00884838105508(21)34093, (01)00884838105508(21)34095, (01)00884838105508(21)34058, (01)00884838105508(21)34024, (01)00884838105508(21)34059, (01)00884838105508(21)34049, (01)00884838105508(21)34056, (01)00884838105508(21)550015, (01)00884838105508(21)34055, (01)00884838105508(21)550031, (01)00884838085015(21)540020, (01)00884838105508(21)34091, (01)00884838105508(21)34052, (01)00884838105508(21)34060, (01)00884838105508(21)34100, (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.
Root Cause
Software design
Action Taken
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.