PlainRecordsFDA · Medical device recall
Incisive CT… and 1 more product
- 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 contact with other components located within the Incisive CT systems during rotation. Other components could be…
- 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…
- Enforcement report date
- Dec. 10, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed 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 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.
- Distribution pattern
- 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, Cte 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, Runion, 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, Trkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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.”Incisive CT; Software Version Number: 4.5, 5.0, 5.1;, FDA enforcement report, 2025-12-10. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: System, X-Ray, Tomography, Computed
2 products in this recall
Incisive CT…
- Product
- Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
- Quantity
- 2341 units
- Codes and lots
- 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, 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550017, 550055, 552026…
- The first 12,000 characters of this field; the agency record has the rest.
- Recall started
- Oct. 29, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On October 23, 2025 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Please continue to use your system in accordance with its intended use and do not stay in the scan room when scanning. 2. Circulate this URGENT Medical Device Correction letter to all users of this device so that they are aware of the issue. 3. Place this URGENT Medical Device Correction with your system documentation and ensure the letter is in a place likely to be seen/viewed. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the tube heat exchanger screws and correct the loosen screw if necessary (reference FCO72800842). Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: For North America, contact the Customer Care Solutions Center {1-800-722-9377, 8AM - 8PM EST, Monday-Friday).
- Recall number
- Z-0881-2026
CT 5300; Software Version Number: 4.5, 5.0, 5.1
- Product
- CT 5300; Software Version Number: 4.5, 5.0, 5.1;
- Quantity
- 6 units (OUS only)
- Codes and lots
- 1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;
- Recall started
- Oct. 29, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- On October 23, 2025 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Please continue to use your system in accordance with its intended use and do not stay in the scan room when scanning. 2. Circulate this URGENT Medical Device Correction letter to all users of this device so that they are aware of the issue. 3. Place this URGENT Medical Device Correction with your system documentation and ensure the letter is in a place likely to be seen/viewed. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the URGENT Medical Device Correction letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect the tube heat exchanger screws and correct the loosen screw if necessary (reference FCO72800842). Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: For North America, contact the Customer Care Solutions Center {1-800-722-9377, 8AM - 8PM EST, Monday-Friday).
- Recall number
- Z-0882-2026
This recall among the others
- FDA's enforcement report came 42 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Philips North America: 66 other recalls or notices on this site in the three years before this one (from Dec. 11, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-0881-2026, Z-0882-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0881-2026, Dec. 10, 2025. "Incisive CT… and 1 more product." PlainRecords, https://plainrecords.com/recall/device/z-0881-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections