Z-0881-2026Class II
Incisive CT; Software Version Number: 4.5, 5.0, 5.1
Philips North America LLC / initiated 2025-10-29 / Open, Classified
Philips North America Llc began a recall of Incisive CT; Software Version Number: 4.5, 5.0, 5.1 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0881-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
- Product code
- JAK System, X-Ray, Tomography, Computed
- 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.
- FDA root cause
- Under Investigation by firm
- Action
- 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).
- Quantity in commerce
- 2341 units
- 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.
- Product 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, 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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, 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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;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0881-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0882-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.