Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Summary

The FDA issued a Class II for Incisive CT; Software Version Number: 4.5, 5.0, 5.1; by Philips North America Llc. Reason: If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make conta.

Details

Product Description

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Lot/Code Info: 1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102, 500145, 500178, 500255, 500217, 500211, 500216, 500225, 33009, 500242, 500252, 500222, 500282, 33005, 500301, 33001, 33035, 33039, 33002, 33003, 33007, 33013, 33047, 33011, 33008, 33015, 33020, 33010, 33046, 33017, 33019, 33049, 33016, 33024, 33006, 33025, 33034, 33041, 33038, 33031, 33042, 33033, 33037, 33045, 33012, 500032, 500073, 500138, 500308, 33023, 500443, 500410, 500412, 500557, 500038, 500069, 500332, 500397, 510056, 500091, 500135, 510028, 510029, 500591, 500123, 500087, 500136, 500103, 500116, 500105, 500056, 500125, 500041, 500089, 500200, 500152, 500219, 500256, 500213, 500307, 510001, 500233, 500371, 500370, 500377, 510030, 510032, 510031, 500360, 510005, 510020, 500329, 500361, 500436, 500457, 500406, 500465, 500525, 500535, 510027, 500523, 33043, 500028, 500024, 500122, 500173, 510095, 500374, 500003, 500020, 500052, 500075, 500118, 500149, 500150, 500134, 500146, 500218, 500223, 500232, 500299, 500311, 500394, 500435, 500463, 33028, 500480, 500078, 500157, 500153, 500229, 500276, 500310, 500300, 500318, 500336, 500347, 500423, 500372, 500357, 500597, 500351, 500363, 500414, 500390, 500448, 500598, 500399, 500405, 500428, 500391, 500524, 500498, 500422, 500526, 500542, 500541, 500565, 500575, 500578, 500592, 500585, 500593, 500586, 500604, 500581, 500577, 500393, 500210, 500296, 510050, 510026, 500049, 500067, 500076, 500081, 500249, 500368, 500415, 500426, 500522, 500550, 500554, 500569, 500567, 500494, 500187, 500129, 500161, 500175, 500156, 500186, 500141, 500142, 500143, 500144, 500160, 500155, 500185, 500204, 500181, 500182, 500191, 500190, 500201, 500228, 500220, 500221, 500272, 500235, 500237, 500262, 500267, 500268, 500250, 500278, 500275, 500284, 500285, 500287, 500288, 500286, 500293, 510009, 510002, 500334, 510010, 510015, 510016, 500400, 510019, 500438, 510022, 500468, 500442, 510035, 510024, 500458, 510044, 510034, 500528, 500527, 500540, 510037, 510049, 510055, 510060, 510057, 510048, 510066, 510064, 510068, 510065, 510070, 510078, 510071, 510067, 500601, 500576, 500603, 500596, 500617, 510073, 510074, 510075, 510082, 500607, 500606, 500594, 500599, 510076, 510077, 500605, 510081, 510079, 500608, 500609, 500610, 500612, 500611, 510080, 500613, 510083, 510090, 500179, 500195, 500258, 510008, 500384, 510017, 510023, 500483, 500440, 510061, 500446, 500471, 500532, 500556, 500568, 500031, 500159, 500074, 500240, 500615, 500002, 500035, 500040, 500158, 500427, 500043, 500097, 500263, 510059, 500205, 500382, 500184, 500274, 500344, 500392, 500203, 500407, 510069, 500128, 500460, 500238, 500080, 500563, 500126, 500207, 500206, 500338, 510036, 510041, 510038, 510042, 510063, 510062, 510058, 500564, 500572, 500449, 510091, 510088, 510094, 500171, 33032, 33026, 33027, 33044, 33036, 500183, 500188, 500194, 500059, 500403, 500245, 500248, 500051, 500189, 500589, 500172, 500433, 500199, 500402, 500176, 500177, 500552, 500614, 500196, 500424, 500010, 500044, 500227, 500226, 500036, 500047, 500079, 500096, 500409, 500212, 500106, 500241, 500488, 500461, 500472, 500314, 500328, 500339, 500375, 500333, 500487, 500470, 500476, 500071, 500082, 500060, 500099, 500121, 500113, 500120, 500163, 500124, 500215, 500251, 500253, 500254, 500257, 500247, 500273, 500269, 500270, 500271, 500279, 500320, 500356, 500343, 500313, 500321, 500316, 500322, 500324, 500373, 500359, 500330, 500364, 500401, 500459, 500383, 500319, 500350, 510013, 500469, 500416, 500473, 500489, 33029, 500533, 500545, 510052, 500546, 500549, 500553, 500551, 500559, 500618, 33030, 33040, 500083, 500132, 500467, 500478, 500445, 500108, 500112, 500164, 500244, 500331, 500341, 500342, 500386, 500385, 500434, 500451, 500479, 500570, 500571, 500583, 500584, 500590, 500600, 500001, 500004, 500013, 500012, 500014, 500039, 500011, 500054, 500017, 500058, 500045, 500055, 500493, 500197, 500090, 500127, 500131, 500303, 500621, 500346, 500302, 500306, 500353, 500352, 500378, 500354, 500395, 500413, 500623, 500619, 500624, 500622, 500337, 500349, 500450, 500464, 500455, 500490, 500456, 500437, 500482, 500486, 500558, 500562, 500484, 500474, 500485, 500497, 500491, 500495, 500496, 500492, 500616, 500588, 500555, 500561, 500566, 500154, 500139, 500162, 500231, 500539, 500066, 500008, 500026, 500109, 500048, 500137, 500068, 500100, 500367, 500379, 500107, 500305, 500209, 510011, 500174, 500345, 500224, 500214, 510006, 500234, 500239, 510003, 500323, 500326, 500325, 510018, 510033, 500521, 510021, 33022, 500444, 500602, 500317, 500019, 500023, 500018, 500029, 500061, 500104, 500169, 500430, 500208, 500198, 500180, 510004, 510007, 500348, 500595, 500130, 500167, 500114, 500165, 500166, 500312, 510072, 500042, 510025, 500429, 500513, 530001, 530003, 530002, 530004, 530269, 530032, 530008, 530007, 530059, 530005, 530006, 530010, 530009, 530078, 530317, 530062, 530060, 530051, 530044, 530047, 530063, 530054, 530045, 530113, 530015, 530014, 530020, 530026, 530019, 530011, 530013, 530017, 530041, 530018, 530016, 530021, 530056, 530070, 530061, 530057, 530022, 530028, 530024, 530025, 530027, 530023, 530353, 530030, 530038, 530029, 530031, 530012, 530043, 530195, 530033, 530034, 530042, 530037, 530036, 530048, 530053, 530035, 530046, 530171, 530039, 530064, 530040, 530049, 530067, 530071, 530084, 530068, 530052, 530079, 530050, 530082, 530066, 530074, 530058, 530055, 530075, 530069, 530081, 530136, 530073, 530086, 530083, 530065, 530077, 530076, 530072, 530093, 530104, 530094, 530091, 530112, 530085, 530080, 530097, 530087, 530099, 530330, 530176, 530092, 530089, 530174, 530280, 530103, 530316, 530117, 530244, 530102, 530107, 530109, 530300, 530118, 530098, 530241, 530090, 530130, 530088, 530101, 530100, 530131, 530126, 530125, 530114, 530111, 530105, 530106, 530120, 530116, 530096, 530134, 530407, 530121, 530319, 530139, 530127, 530140, 530095, 530115, 530129, 530108, 530142, 530138, 530144, 530141, 530133, 530128, 530302, 530181, 530167, 530182, 530217, 530149, 530246, 530145, 530304, 530219, 530151, 530148, 530283, 530150, 530122, 530173, 530211, 530110, 530216, 530166, 530170, 530153, 530218, 530164, 530221, 530168, 530299, 530322, 530158, 530223, 530157, 530162, 530184, 530206, 530180, 530163, 530143, 530210, 530177, 530188, 530198, 530205, 530240, 530215, 530268, 530214, 530232, 530245, 530230, 530231, 530417, 530321, 530190, 530192, 530194, 530169, 530193, 530213, 530123, 530395, 530156, 530209, 530197, 530196, 530183, 530248, 530247, 530237, 530228, 530313, 530251, 530242, 530265, 530258, 530281, 530593, 530341, 530270, 530286, 530261, 530542, 530267, 530284, 530199, 530276, 530224, 530340, 530239, 530279, 530271, 530235, 530277, 530243, 530262, 530377, 530259, 530278, 530289, 530391, 530288, 530249, 530364, 530285, 530381, 530257, 530260, 530392, 530295, 530305, 530314, 530297, 530333, 530266, 530312, 530290, 530310, 530309, 530327, 530292, 530355, 530324, 530411, 530308, 530323, 530274, 530356, 530371, 530343, 530315, 530325, 530579, 530287, 530574, 530352, 530386, 530383, 530336, 530334, 530382, 530402, 530367, 530375, 530347, 530365, 530444, 530390, 530361, 530418, 530447, 530351, 530346, 530441, 530366, 530410, 530572, 530451, 530478, 530434, 530422, 530423, 530376, 530477, 530429, 530380, 530412, 530359, 530403, 530413, 530414, 530594, 530393, 530405, 530469, 530416, 530471, 530379, 530387, 530385, 530406, 530397, 530440, 530433, 530442, 530424, 530450, 530571, 530394, 530396, 530400, 530399, 530401, 530398, 530426, 530425, 530445, 530454, 530465, 530427, 530497, 530472, 530457, 530428, 530496, 530453, 530467, 530448, 530455, 530438, 530536, 530439, 530446, 530479, 530463, 530459, 530526, 530443, 530513, 530468, 530473, 530484, 530566, 530511, 530512, 530485, 530538, 530487, 530488, 530493, 530491, 530495, 530490, 530499, 530498, 530504, 530503, 530505, 530522, 530583, 530517, 530541, 530544, 530516, 530518, 530556, 530520, 530570, 530519, 530560, 530557, 530525, 530532, 530528, 530558, 530587, 530555, 530531, 530540, 530546, 530539, 530548, 530553, 530551, 530568, 530573, 530586, 530582, 530565, 530580, 530590, 530595, 510014, 500396, 500579, 530354, 500193, 500098, 500327, 500419, 500420, 500388, 500093, 500355, 500380, 510053, 500070, 500065, 500261, 500441, 510012, 500432, 500006, 500447, 500580, 500620, 500304, 500587, 500117, 500404, 500366, 500417, 500007, 500025, 500022, 500033, 500037, 500057, 500027, 500151, 500408, 500050, 500063, 500072, 500094, 500147, 500148, 500398, 500243, 500236, 500246, 500260, 500277, 500335, 510000, 500315, 500369, 500389, 500381, 500466, 500475, 500547, 510054, 500021, 500115, 500053, 500095, 500077, 500170, 500362, 500560, 500230, 500573, 500582; 2) Model Number: 728144; UDI-DI: 00884838105508; Serial numbers: 552070, 552094, 34415, 34010, 552036, 550138, 550133, 552051, 550320, 550076, 550319, 550190, 550230, 550231, 550374, 550126, 34002, 34006, 34007, 34025, 34026, 34018, 34023, 34031, 34033, 34032, 34038, 34041, 34042, 34040, 34051, 34047, 34050, 34049, 34052, 34053, 34054, 34056, 34057, 34055, 34060, 34058, 34059, 34064, 34066, 34072, 34067, 34068, 34071, 34074, 34073, 34078, 34079, 34075, 34077, 34082, 34081, 34083, 34085, 34088, 34090, 34086, 34092, 34091, 34093, 34089, 34112, 34095, 34103, 34097, 34100, 34106, 34102, 34101, 34105, 34111, 34117, 34119, 34116, 34134, 34131, 34133, 34122, 34132, 34137, 34135, 550243, 34126, 34149, 34146, 34128, 34150, 34164, 34162, 34165, 34168, 34169, 34174, 34179, 34187, 34190, 34198, 34195, 34193, 34203, 34191, 34201, 34206, 34208, 34163, 34152, 34160, 34221, 34218, 34226, 34235, 34223, 34240, 34229, 34251, 34153, 34175, 34257, 34259, 34260, 34263, 34265, 34267, 34276, 34277, 34282, 34280, 34279, 34281, 34285, 34294, 34315, 34301, 34324, 34327, 34325, 34289, 34338, 34326, 34337, 34351, 500452, 550016, 550040, 34001, 34151, 34004, 550035, 34166, 552133, 552034, 550165, 550216, 550218, 550242, 34254, 34306, 552086, 500507, 500537, 550027, 550029, 34044, 550090, 550154, 34129, 550295, 34196, 34156, 34209, 550122, 552135, 552134, 550476, 550019, 552002, 500520, 552000, 510040, 510043, 500536, 550000, 550014, 552017, 550088, 550053, 550089, 552005, 552021, 552043, 550132, 550127, 550105, 550160, 550179, 550292, 550262, 550263, 550264, 550271, 550158, 552029, 552056, 552057, 552058, 552067, 552076, 552075, 552074, 550299, 550361, 550343, 550257, 550304, 550244, 550429, 550413, 550193, 550278, 550256, 550261, 550313, 550297, 552114, 552118, 552117, 552115, 552121, 552110, 552090, 552109, 552105, 552081, 550394, 550431, 550446, 550430, 550455, 550497, 550500, 550481, 550444, 550482, 550451, 550443, 550432, 550485, 550463, 552125, 552129, 552128, 552131, 552130, 552126, 552123, 552127, 550504, 550506, 550513, 550507, 550412, 34043, 34065, 34084, 34061, 34180, 34186, 34211, 34212, 34273, 34317, 34349, 552085, 500502, 510039, 550092, 550104, 550162, 550181, 550185, 550200, 550298, 552104, 34274, 552111, 55400406110846, 500283, 550453, 500340, 500499, 550093, 550096, 34142, 34108, 34161, 34177, 34194, 34219, 34246, 34255, 550251, 34217, 34252, 34147, 34127, 550203, 550296, 550234, 550266, 34157, 550300, 550291, 550248, 34176, 34253, 550301, 34239, 34224, 34227, 34216, 34309, 550111, 550147, 550163, 550362, 550280, 550201, 550202, 550307, 550281, 550283, 550284, 550235, 550387, 550496, 550333, 550414, 550347, 550462, 550419, 550404, 550399, 550356, 550461, 550420, 550458, 550511, 552006, 552007, 552009, 552016, 550091, 552023, 552037, 550353, 550210, 550228, 550240, 552101, 550403, 550489, 550135, 550366, 550021, 552020, 552032, 550087, 550123, 550155, 550418, 550302, 550509, 550078, 550503, 552052, 540020, 540021, 552050, 541001, 550221, 550222, 550223, 550224, 552054, 550253, 552060, 552059, 552062, 550273, 550287, 550288, 550289, 552069, 550439, 550324, 550325, 552065, 550318, 550317, 550322, 552113, 552001, 550017, 550055, 552026, 550252, 552038, 552040, 552042, 550173, 34118, 552048, 34171, 34233, 55400406111117, 34319, 552031, 552030, 552053, 550293, 552071, 552073, 550043, 550141, 550115, 34110, 34121, 550058, 34062, 34104, 550180, 34145, 34272, 550211, 550229, 34238, 34249, 55400406111136, 550464, 550465, 550466, 550473, 550474, 550469, 550470, 55400406111636, 550099, 550175, 550378, 550415, 552116, 550457, 550039, 550067, 550424, 550233, 550006, 550411, 550396, 550428, 550003, 34063, 550101, 552049, 550151, 550440, 550512, 550110, 550192, 550352, 55400406111064, 550114, 550308, 550448, 552033, 552046, 500259, 510046, 500511, 552047, 550310, 34237, 550422, 550427, 550477, 550479, 550478, 550501, 552100, 550062, 550048, 550456, 552098, 55400406111276, 34395, 552082, 550425, 34370, 34361, 34369, 34365, 34360, 550226, 550225, 550407, 550232, 550249, 34284, 34346, 552061, 55400406111221, 55400406111210, 55400406111211, 55400406111437, 55400406111438, 55400406111457, 55400406111458, 552066, 554173, 500514, 550184, 552044, 550209, 550217, 550337, 55400406111026, 500504, 550102, 550433, 550524, 552004, 34286, 550270, 550486, 500517, 500519, 550024, 550206, 550207, 550214, 552083, 552084, 552099, 550144, 552024, 552027, 550294, 550338, 55400406111115, 552119, 550212, 500501, 500506, 550065, 500516, 550001, 550005, 550025, 550066, 550034, 550157, 550050, 550309, 550326, 550059, 550134, 550204, 550069, 550452, 550402, 550176, 550236, 550174, 550186, 550130, 550150, 550140, 550164, 550213, 550363, 550306, 550265, 550312, 550305, 550468, 500358, 550026, 550032, 34008, 550046, 34009, 34028, 550051, 34022, 34037, 34034, 34027, 34046, 34016, 34024, 34184, 34069, 34039, 34048, 552015, 550070, 34199, 34087, 34183, 34036, 34124, 552039, 34120, 34144, 34140, 34123, 34138, 34173, 34172, 34215, 34241, 34188, 34189, 34185, 34220, 34231, 34222, 34232, 34214, 34234, 34230, 34243, 34225, 34250, 34262, 34258, 34275, 34148, 34266, 34278, 34283, 55400406111183, 34287, 34271, 34288, 55400406110942, 34291, 34290, 34292, 55400406111085, 34298, 34297, 34299, 34300, 34302, 34305, 55400406111082, 34308, 34321, 55400406111099, 34328, 55400406111229, 34330, 34336, 34347, 34355, 34353, 34354, 55400406111895, 550510, 55400406111876, 55400406111644, 500411, 34021, 34076, 34094, 34154, 34213, 550449, 34320, 34322, 550085, 550327, 550346, 55400406111961, 55400406111960, 550367, 550377, 550368, 550372, 550380, 550370, 550371, 550369, 550379, 550376, 552072, 550351, 550358, 550360, 550357, 550359, 550365, 550339, 550342, 550340, 550341, 550348, 550349, 550350, 550131, 550139, 550145, 550167, 550166, 550171, 550178, 550197, 550198, 550267, 550275, 552078, 552079, 550344, 550345, 552080, 552087, 550364, 552088, 552089, 552093, 552092, 550373, 552096, 552095, 550405, 550406, 552102, 550435, 550450, 550454, 500531, 550002, 500529, 34014, 34013, 552003, 550018, 550075, 550073, 550074, 34109, 550113, 550112, 550095, 34113, 34139, 34167, 34261, 34178, 550238, 550254, 550279, 550303, 550268, 550336, 550290, 550408, 550409, 34323, 550395, 550421, 550417, 550426, 550442, 34311, 34314, 34310, 550472, 34312, 34316, 550022, 550152, 550041, 550100, 550447, 550128, 34228, 500266, 34015, 34197, 34210, 34268, 500387, 500005, 500062, 500418, 500453, 500530, 550008, 34247, 550010, 500515, 550097, 550036, 550172, 552011, 34011, 34020, 550082, 550071, 552028, 550094, 552018, 550148, 34155, 550136, 550142, 34107, 550177, 552045, 34141, 550205, 550215, 550237, 550247, 34182, 550282, 34204, 550311, 550328, 550332, 550393, 55400406110738, 552097, 55400406110740, 550401, 55400406110607, 34269, 552112, 34293, 34307, 34318, 55400406111033, 34329, 550467, 550487, 34364, 550494, 550499, 550502, 55400406111629, 34303, 34296, 500030, 500119, 500133, 500462, 55400406111352, 500508, 500509, 550118, 500505, 500538, 500500, 500503, 550015, 550194, 550047, 550106, 550020, 550086, 550023, 55400406111422, 550042, 550079, 550103, 550056, 550054, 552013, 552025, 550274, 550107, 34236, 550081, 550121, 34158, 550077, 34070, 550143, 34242, 550323, 550120, 550129, 34245, 550182, 550119, 550314, 550109, 550286, 550169, 550434, 34136, 552077, 34207, 55400406110840, 55400406111002, 550321, 34248, 34256, 34304, 500365, 500425, 500431, 500421, 500477, 33021, 500439, 33018, 550013, 550438, 500512, 550246, 550245, 550012, 550044, 550049, 550125, 550098, 552035, 550189, 550331, 552091, 550354, 550459, 550084, 552041, 500192, 550255, 550188, 34202, 550285, 500298, 34125, 34192, 550330, 550161, 55400406111118, 55400406111198, 34362, 34357, 34372, 550227, 550334, 550445, 550007, 550068, 550239, 550009, 550057, 550108, 550117, 550137, 550191, 550269, 552106, 552132, 554251, 554269, 554272, 554010, 554008, 554004, 554103, 554000, 556000, 554072, 554016, 554007, 554003, 554018, 554001, 554009, 554205, 554002, 554005, 554006, 556001, 556002, 554012, 554017, 554015, 554011, 554020, 554013, 554014, 554019, 554021, 554022, 554023, 554026, 554025, 554024, 554028, 554027, 554035, 554033, 554067, 554095, 554052, 554034, 554068, 554211, 554061, 554219, 554200, 554092, 554097, 554159, 554048, 554077, 554107, 554049, 554194, 554050, 554171, 554156, 554047, 554138, 554043, 554044, 554176, 554063, 554082, 554071, 554086, 554195, 556003, 556004, 554081, 554147, 556005, 554133, 554083, 554074, 554113, 554108, 554085, 554070, 554073, 554111, 554136, 554120, 554222, 554109, 554091, 554127, 554158, 554188, 554088, 554099, 554093, 554100, 554096, 554172, 554149, 554106, 554114, 554166, 554104, 554128, 554094, 554129, 554123, 554102, 554115, 554121, 554119, 554124, 554122, 554155, 554135, 554170, 554235, 554163, 554199, 554143, 554169, 554160, 554141, 554148, 554157, 554203, 554144, 554140, 554131, 554150, 554161, 554152, 554227, 554151, 554226, 554154, 554224, 554162, 554185, 554206, 554207, 554182, 554181, 554165, 554175, 554177, 554178, 554184, 554234, 554179, 554180, 554220, 554187, 554191, 554197, 554202, 554216, 554204, 554208, 554212, 554192, 554223, 554183, 554196, 554198, 554221, 554217, 554213, 554228, 554230, 554215, 554229, 554210, 554209, 554236, 554218, 554232, 554233, 554238, 554237, 554240, 552014, 510047, 510045, 550011, 550028, 550038, 550064, 550168, 552055, 550355, 550410, 550471, 550498, 34019, 550149, 550495, 550031, 550388, 34170, 550156, 550260, 550277, 34045, 550124, 550170, 550460, 550523, 34114, 34115, 34005, 550315, 500454, 550004, 550030, 550033, 550063, 552008, 550052, 552010, 550116, 550146, 550159, 550187, 550195, 550196, 550241, 550250, 550259, 550381, 550392, 550397, 500481, 500518, 550037, 550045, 552019, 550072, 550060, 550061, 552012, 550199, 550083, 550080, 552022, 550153, 550272, 552068, 550383, 550183, 550208, 550258, 550329, 550382, 550385, 550384, 550386, 550389, 550390, 550391, 550398, 550400, 550416, 552122, 552103, 552107, 34035, 34030, 34029;

Quantity Affected: 2341 units

Reason for Recall

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-10-29

Company