Exact FDA event identifier

Event 97919

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 29, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Philips North America Llc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0881-2026

Recall number: Z-0881-2026
Initiated: October 29, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 2341 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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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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;

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, 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.

device · product 2 of 2

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

Z-0882-2026

Recall number: Z-0882-2026
Initiated: October 29, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 6 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

1) Model Number: 728285; UDI-DI: 00884838113237; Serial Numbers: 35071, 800007, 800002, 800001, 800004, 800003;