Use caution Medical device recall · FDA · Published October 29, 2025

Philips CT 5300 Software Version 4.5-5.1 Recall: Risk of Component Detachment

Philips recalls CT 5300 scanners with software versions 4.5, 5.0, and 5.1 due to potential tube heat exchanger detachment causing damage. Affected units have specific serial numbers and model numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0882-2026Medical device Philips ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling CT 5300 medical scanners with software versions 4.5, 5.0, and 5.1. If the tube heat exchanger screws aren't tightened properly after replacement, it could detach and damage other components during operation. Read more at govinfonow.com/recall/50887-philips-ct-5300-software-version-4-5-5-1-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/50887-philips-ct-5300-software-version-4-5-5-1-recall · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0882-2026

Cite this page

“Philips CT 5300 Software Version 4.5-5.1 Recall: Risk of Component Detachment.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50887-philips-ct-5300-software-version-4-5-5-1-recall. Based on FDA recall #Z-0882-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0882-2026%22&limit=1).

Philips North America Llc recalled CT 5300 units with software versions 4.5, 5.0, and 5.1 due to a hazard where loose screws on the tube heat exchanger may detach and damage other components. The Food and Drug Administration announced this voluntary Class II recall on October 29, 2025.

How to tell if you have it

Brand: Philips
Product: CT 5300
Software Version Number: 4.5, 5.0, 5.1
Model Number: 728285
UDI-DI: 00884838113237
Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003

The hazard

If the screws of the tube heat exchanger on the rotating scanner are not tightened well after replacement, the component may become detached and contact other components within the Incisive CT systems during rotation. This contact could damage other components.

Context

GovInfoNow's records show Philips North America Llc has issued 129 other recalls since July 12, 2017. Recent similar recalls include a Philips Incisive CT recall for an unstable sensor on December 3, 2025, and a Philips Incisive CT software recall for potential bolus tracking failure on June 26, 2026.

How to tell if you have this one

Check for model number 728285 and serial numbers 35071, 800001-800004. The software versions 4.5, 5.0, and 5.1 are also affected.

Brand
Philips
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Ethiopia, France, FrenchPolynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua Nw Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Serbia, Sint Maarten (D, Slovakia, South Africa, South Korea, Spain, St.Pier,Miquel., Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

Recall number	Product, codes & lots	Quantity
Z-0881-2026	Incisive CT; Software Version Number: 4.5, 5.0, 5.1;; 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, 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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;	2341 units
Z-0882-2026	CT 5300; Software Version Number: 4.5, 5.0, 5.1;; 1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;	6 units (OUS only)

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your CT 5300 scanner to see if it is 4.5, 5.0, or 5.1.
Inspect Screws
Ensure the screws securing the tube heat exchanger are tightened properly after any replacement.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

Oct 29, 2025Firm started the recall
Dec 3, 2025FDA classified it Class II
Dec 10, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50887-philips-ct-5300-software-version-4-5-5-1-recall">Philips CT 5300 Software Version 4.5-5.1 Recall: Risk of Component Detachment (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0882-2026 (October 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0882-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.