The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross

Summary

The FDA issued a Class II for The device is a whole-body CT x-ray system. The acquired x-ray transmission data by Philips North America Llc. Reason: Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect i.

Details

Product Description

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.

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, 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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, 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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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Quantity Affected: 330 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-03-29

Company