Recall archive / FDA device enforcement
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cr... — FDA record Z-0576-2024
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 330 units
- Agency-reported status
- Completed
- Source record identifier
- Z-0576-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, 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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,... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Mar 29, 2022
- Center classification date
- Dec 18, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.